Trial Outcomes & Findings for A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects (NCT NCT02688387)
NCT ID: NCT02688387
Last Updated: 2019-01-22
Results Overview
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time points for analysis of ambrisentan and tadafil. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 1 of the study. The analysis was performed on Pharmacokinetic (PK) parameter population, which included all participants who provided PK parameter data.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
112 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Results posted on
2019-01-22
Participant Flow
This was a single dose, randomized, open-label, crossover study in healthy participants. A total of 112 healthy participants were randomized and received the study treatment. The study was conducted at a single center in the United Kingdom.
A total of 174 participants were screened, of which 59 were screen failures and 3 participants were reserve participants. Thus 112 participants were randomized. The study, was conducted in three parts: Part 1 (5 way crossover) and Parts 2 and 3 (A and B), followed 4 way crossover design.
Participant milestones
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Part 1, F2/ F3/ F1/ F4/ R
The eligible participants in the Sequence (F2/ F3/ F1/ F4/ R) received a single oral dose of fixed dose combination (FDC) for GSK3380154 (ambrisentan 10 milligram \[mg\] + tadalafil 40 mg). Participants received single oral dose F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg Sodium laurilsulfate \[SLS\]) during Period 1, followed by single oral dose F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS) during Period 2, followed by single oral dose F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS) during Period 3, followed by a single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 4, which was followed by a single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 1, R/ F1/ F4/ F2/ F3
The eligible participants in the Sequence (R/ F1/ F4/ F2/ F3), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 1, followed by single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS) during Period 2, followed by a single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 3, followed by single oral dose F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS during Period 4, followed by single oral dose F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS) during Period 5.Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 1, F4/ F3/ R/ F2/ F1
The eligible participants in the Sequence (F4/ F3/ R/ F2/ F1), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 1, followed by single oral dose F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS) during Period 2, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 3, followed by single oral dose F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 4, followed by single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 1, F2/ F1/ F3/ R/ F4
The eligible participants in the Sequence (F2/ F1/ F3/ R/ F4), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 1, followed by single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 2, followed by single oral dose F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS) during Period 3, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 4, followed by single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 1, F3/ F2/ F4/ F1/ R
The eligible participants in the Sequence (F3/ F2/ F4/ F1/ R), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 1, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 2, followed by single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 3, followed by single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 4, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 1, F1/ F2/ R/ F3/ F4
The eligible participants in the Sequence (F1/ F2/ R/ F3/ F4), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS) during Period 1, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 2, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 3, followed by a single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 4, followed by single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS)during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 1, F3/ F4/ F2/ R/ F1
The eligible participants in the Sequence (F3/ F4/ F2/ R/ F1), , received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 1, followed by single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 2, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 3, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 4, followed by received single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS) during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 1, F4/ R/ F3/ F1/ F2
The eligible participants in the Sequence (F4/ R/ F3/ F1/ F2), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS)during Period 1, followed by a single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently during Period 2,followed by a single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 3, followed single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 4, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 1, R/ F4/ F1/ F3/ F2
The eligible participants in the Sequence (R/ F4/ F1/ F3/ F2), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently during Period 1, followed by a single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 2, followed single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 3, followed by a single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 4, followed by a s ingle oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 1, F1/ R/ F2/ F4/ F3
The eligible participants in the Sequence (F1/ R/ F2/ F4/ F3), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS),during Period 1, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently during Period 2, followed by a s ingle oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 3, followed by a single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 4, followed by a single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 2, R/ FG1/ FG3/ FG2
The eligible participants in the Sequence (R/ FG1/ FG3/ FG2) were administered the 2 monotherapies ambrisentan and tadalafil concurrently, during Period 1, this was followed by single oral dose of FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg), with formulation selected from Part 1, during Period 2, this was followed by the single oral dose of FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1 during Period 3, this was followed by single oral dose of the FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1, administered during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 2, FG1/FG2/R/ FG3
The eligible participants in the Sequence (FG1/FG2/R/ FG3) were administered single oral dose of FG1 given as FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg), with formulation selected from Part 1, during Period 1, this was followed by the single oral dose of FG2 given as FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1 during Period 2, this was followed by the 2 monotherapies R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil concurrently, from the formulation selected from Part 1, given during Period 3, this was followed by single oral dose of FG3 given as FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1, administered during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 2, FG2/ FG3/ FG1/ R
The eligible participants in the Sequence (FG2/ FG3/ FG1/ R), were administered single oral dose of FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1 during Period 1, this was followed by single oral dose of the FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1, administered during Period 2, this was followed by single oral dose of FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg), with formulation selected from Part 1, during Period 3, this was followed by the 2 monotherapies R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil concurrently, from the formulation selected from Part 1, given during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 2, FG3/ R/ FG2/ FG1
The eligible participants in the Sequence (FG3/ R/ FG2/ FG1),were administered with single oral dose of the FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1, administered during Period 1, this was followed by the 2 monotherapies R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil concurrently, from the formulation selected from Part 1, given during Period 2, this was followed by single oral dose of FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1 during Period 3, this was followed by single oral dose of FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg), with formulation selected from Part 1, during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
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Part 3A, X2/ R2/ R1/ X1
Eligible participants received single oral dose of X2 as FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (granular formulation selected from Part 2), under fasted state during Period 1, followed by single oral dose of R2 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state during Period 2, this was followed by a single oral dose of R1 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state, comprising of high fat diet during Period 3, followed by a single oral dose of X1 where participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state, which comprised of high fat diet, during Period 4. Overall treatment period was of 4-weeks. Each dose taken either under fed or fasted condition and separated by washout period of 10-Days.
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Part 3A, ,X1/ R1/ R2/ X2
Eligible participants received single oral dose of X1 where participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state, which comprised of a high fat diet, during Period 1, followed by single oral dose of R1 where participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state, comprising of high fat diet during Period 2, followed by single oral dose of R2 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state during Period 3, followed by single oral dose of X2 as FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state during Period 4. Overall treatment period was of 4-weeks. Each dose taken either under fed or fasted condition and separated by washout period of 10-Days.
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Part 3A, R1/ X2/ X1/ R2
Eligible participants were administered single oral dose of R1 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state, comprising of high fat diet during Period 1, followed by single oral dose of X2 as FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state during Period 2, followed by single oral dose of X1 where participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state, comprising high fat diet, during Period 3, followed by single oral dose of R2 where participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
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Part 3A, ,R2/ X1/ X2/ R1
Eligible participants were administered single oral dose of R2 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state during Period 1, followed by single oral dose of X1 where participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state, which comprised of high fat diet, during Period 2, followed by single oral dose of X2 as FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (granular formulation selected from Part 2), under fasted state during Period 3, followed by single oral dose of R1 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state, comprising high fat diet during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fed or fasted condition and separated by washout period of 10-Days.
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Part 3B, Y1/ R3/ R4/ Y2
The eligible participants in the Sequence (Y1/ R3/ R4/ Y2), where participants for Y1 dose were administered a single oral dose of FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose during Period 1, this was followed by a single oral dose of R3 the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg during Period 2, this was followed by a single oral dose of R4, where the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state, during Period 3, this was followed by Y2 dose where the participants received a single oral dose of received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state, during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
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Part 3B, R3/ Y2/ Y1/ R4
The eligible participants in the Sequence (R3/ Y2/ Y1/ R4), where the participants for R3 dose were administered a single oral dose of the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose, during Period 1, this was followed by the Y2 dose, where the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose during Period 2, this was followed by the Y1 dose where the participants were administered a single oral dose of FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose during Period 3, this was followed by a single oral dose of R4, where the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state, during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
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Part 3B, Y2/ R4/ R3/ Y1
The eligible participants in the Sequence (Y2/ R4/ R3/ Y1), received single oral dose of Y2 where the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose during Period 1, this was followed by a single oral dose of R4, where the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state, during Period 2, this was followed by a single oral dose of R3 dose where participants were administered a single oral dose of the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state, during Period 3, this was followed by the Y1 dose where the participants were administered a single oral dose of FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
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Part 3B, R4/ Y1/ Y2/ R3
The eligible participants in the Sequence (R4/ Y1/ Y2/ R3), received single oral dose of R4, where the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state, during Period 1, this was followed by the Y1 dose where the participants were administered a single oral dose of FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose during Period 2, this was followed by single oral dose of Y2 where the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose during Period 3, this was followed by a single oral dose of R3 dose where participants were administered a single oral dose of the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state, during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
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Part 1, Period 1 (up to 6 Days)
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Part 1, Period 1 (up to 6 Days)
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Part 1, Washout Period 1 (7 Days)
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Part 1, Period 2 (up to 6 Days)
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Part 1, Period 2 (up to 6 Days)
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Part 1, Washout Period 2 (7 Days)
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Part 1, Washout Period 2 (7 Days)
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Period 3 (up to 6 Days)
STARTED
|
3
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Period 3 (up to 6 Days)
COMPLETED
|
3
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Period 3 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Washout Period 3 (7 Days)
STARTED
|
3
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Washout Period 3 (7 Days)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Washout Period 3 (7 Days)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Period 4 (up to 6 Days)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Period 4 (up to 6 Days)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Period 4 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Washout Period 4 (7 Days)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Washout Period 4 (7 Days)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Washout Period 4 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Period 5 (up to 6 Days)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Period 5 (up to 6 Days)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Period 5 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 1 (up to 6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 1 (up to 6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 1 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Washout Period 1 (10 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Washout Period 1 (10 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Washout Period 1 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 2 (up to 6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 2 (up to 6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 2 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Washout Period 2 (10 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Washout Period 2 (10 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Washout Period 2 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 3 (up to 6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 3 (up to 6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 3 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Washout Period 3 (10 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Washout Period 3 (10 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Washout Period 3 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 4 (up to 6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 4 (up to 6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 4 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 1 (up to 6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 1 (up to 6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 1 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3A, Washout Period 1 (10 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Washout Period 1 (10 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Washout Period 1 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 2 (up to 6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 2 (up to 6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 2 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3A, Washout Period 2 (10 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Washout Period 2 (10 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Washout Period 2 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 3 (up to 6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 3 (up to 6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 3 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3A, Washout Period 3 (10 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Washout Period 3 (10 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Washout Period 3 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 4 (up to 6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 4 (up to 6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 4 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3B, Period 1 (up to 6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
|
Part 3B, Period 1 (up to 6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
|
Part 3B, Period 1 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3B, Washout Period 1 (10 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
|
Part 3B, Washout Period 1 (10 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
|
Part 3B, Washout Period 1 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3B, Period 2 (up to 6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
|
Part 3B, Period 2 (up to 6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
|
Part 3B, Period 2 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3B, Washout Period 2 (10 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
|
Part 3B, Washout Period 2 (10 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
|
Part 3B, Washout Period 2 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3B, Period 3 (up to 6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
8
|
8
|
|
Part 3B, Period 3 (up to 6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
7
|
8
|
|
Part 3B, Period 3 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 3B, Washout Period 3 (10 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
7
|
8
|
|
Part 3B, Washout Period 3 (10 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
7
|
6
|
8
|
|
Part 3B, Washout Period 3 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
|
Part 3B, Period 4 (up to 6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
7
|
6
|
8
|
|
Part 3B, Period 4 (up to 6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
7
|
6
|
8
|
|
Part 3B, Period 4 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1, F2/ F3/ F1/ F4/ R
The eligible participants in the Sequence (F2/ F3/ F1/ F4/ R) received a single oral dose of fixed dose combination (FDC) for GSK3380154 (ambrisentan 10 milligram \[mg\] + tadalafil 40 mg). Participants received single oral dose F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg Sodium laurilsulfate \[SLS\]) during Period 1, followed by single oral dose F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS) during Period 2, followed by single oral dose F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS) during Period 3, followed by a single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 4, which was followed by a single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 1, R/ F1/ F4/ F2/ F3
The eligible participants in the Sequence (R/ F1/ F4/ F2/ F3), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 1, followed by single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS) during Period 2, followed by a single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 3, followed by single oral dose F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS during Period 4, followed by single oral dose F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS) during Period 5.Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 1, F4/ F3/ R/ F2/ F1
The eligible participants in the Sequence (F4/ F3/ R/ F2/ F1), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 1, followed by single oral dose F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS) during Period 2, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 3, followed by single oral dose F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 4, followed by single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 1, F2/ F1/ F3/ R/ F4
The eligible participants in the Sequence (F2/ F1/ F3/ R/ F4), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 1, followed by single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 2, followed by single oral dose F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS) during Period 3, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 4, followed by single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 1, F3/ F2/ F4/ F1/ R
The eligible participants in the Sequence (F3/ F2/ F4/ F1/ R), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 1, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 2, followed by single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 3, followed by single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 4, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 1, F1/ F2/ R/ F3/ F4
The eligible participants in the Sequence (F1/ F2/ R/ F3/ F4), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS) during Period 1, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 2, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 3, followed by a single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 4, followed by single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS)during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 1, F3/ F4/ F2/ R/ F1
The eligible participants in the Sequence (F3/ F4/ F2/ R/ F1), , received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 1, followed by single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 2, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 3, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 4, followed by received single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS) during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 1, F4/ R/ F3/ F1/ F2
The eligible participants in the Sequence (F4/ R/ F3/ F1/ F2), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS)during Period 1, followed by a single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently during Period 2,followed by a single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 3, followed single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 4, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 1, R/ F4/ F1/ F3/ F2
The eligible participants in the Sequence (R/ F4/ F1/ F3/ F2), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently during Period 1, followed by a single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 2, followed single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 3, followed by a single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 4, followed by a s ingle oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 1, F1/ R/ F2/ F4/ F3
The eligible participants in the Sequence (F1/ R/ F2/ F4/ F3), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS),during Period 1, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently during Period 2, followed by a s ingle oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 3, followed by a single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 4, followed by a single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 2, R/ FG1/ FG3/ FG2
The eligible participants in the Sequence (R/ FG1/ FG3/ FG2) were administered the 2 monotherapies ambrisentan and tadalafil concurrently, during Period 1, this was followed by single oral dose of FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg), with formulation selected from Part 1, during Period 2, this was followed by the single oral dose of FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1 during Period 3, this was followed by single oral dose of the FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1, administered during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 2, FG1/FG2/R/ FG3
The eligible participants in the Sequence (FG1/FG2/R/ FG3) were administered single oral dose of FG1 given as FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg), with formulation selected from Part 1, during Period 1, this was followed by the single oral dose of FG2 given as FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1 during Period 2, this was followed by the 2 monotherapies R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil concurrently, from the formulation selected from Part 1, given during Period 3, this was followed by single oral dose of FG3 given as FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1, administered during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 2, FG2/ FG3/ FG1/ R
The eligible participants in the Sequence (FG2/ FG3/ FG1/ R), were administered single oral dose of FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1 during Period 1, this was followed by single oral dose of the FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1, administered during Period 2, this was followed by single oral dose of FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg), with formulation selected from Part 1, during Period 3, this was followed by the 2 monotherapies R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil concurrently, from the formulation selected from Part 1, given during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 2, FG3/ R/ FG2/ FG1
The eligible participants in the Sequence (FG3/ R/ FG2/ FG1),were administered with single oral dose of the FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1, administered during Period 1, this was followed by the 2 monotherapies R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil concurrently, from the formulation selected from Part 1, given during Period 2, this was followed by single oral dose of FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1 during Period 3, this was followed by single oral dose of FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg), with formulation selected from Part 1, during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
|
Part 3A, X2/ R2/ R1/ X1
Eligible participants received single oral dose of X2 as FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (granular formulation selected from Part 2), under fasted state during Period 1, followed by single oral dose of R2 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state during Period 2, this was followed by a single oral dose of R1 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state, comprising of high fat diet during Period 3, followed by a single oral dose of X1 where participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state, which comprised of high fat diet, during Period 4. Overall treatment period was of 4-weeks. Each dose taken either under fed or fasted condition and separated by washout period of 10-Days.
|
Part 3A, ,X1/ R1/ R2/ X2
Eligible participants received single oral dose of X1 where participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state, which comprised of a high fat diet, during Period 1, followed by single oral dose of R1 where participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state, comprising of high fat diet during Period 2, followed by single oral dose of R2 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state during Period 3, followed by single oral dose of X2 as FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state during Period 4. Overall treatment period was of 4-weeks. Each dose taken either under fed or fasted condition and separated by washout period of 10-Days.
|
Part 3A, R1/ X2/ X1/ R2
Eligible participants were administered single oral dose of R1 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state, comprising of high fat diet during Period 1, followed by single oral dose of X2 as FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state during Period 2, followed by single oral dose of X1 where participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state, comprising high fat diet, during Period 3, followed by single oral dose of R2 where participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
|
Part 3A, ,R2/ X1/ X2/ R1
Eligible participants were administered single oral dose of R2 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state during Period 1, followed by single oral dose of X1 where participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state, which comprised of high fat diet, during Period 2, followed by single oral dose of X2 as FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (granular formulation selected from Part 2), under fasted state during Period 3, followed by single oral dose of R1 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state, comprising high fat diet during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fed or fasted condition and separated by washout period of 10-Days.
|
Part 3B, Y1/ R3/ R4/ Y2
The eligible participants in the Sequence (Y1/ R3/ R4/ Y2), where participants for Y1 dose were administered a single oral dose of FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose during Period 1, this was followed by a single oral dose of R3 the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg during Period 2, this was followed by a single oral dose of R4, where the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state, during Period 3, this was followed by Y2 dose where the participants received a single oral dose of received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state, during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
|
Part 3B, R3/ Y2/ Y1/ R4
The eligible participants in the Sequence (R3/ Y2/ Y1/ R4), where the participants for R3 dose were administered a single oral dose of the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose, during Period 1, this was followed by the Y2 dose, where the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose during Period 2, this was followed by the Y1 dose where the participants were administered a single oral dose of FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose during Period 3, this was followed by a single oral dose of R4, where the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state, during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
|
Part 3B, Y2/ R4/ R3/ Y1
The eligible participants in the Sequence (Y2/ R4/ R3/ Y1), received single oral dose of Y2 where the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose during Period 1, this was followed by a single oral dose of R4, where the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state, during Period 2, this was followed by a single oral dose of R3 dose where participants were administered a single oral dose of the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state, during Period 3, this was followed by the Y1 dose where the participants were administered a single oral dose of FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
|
Part 3B, R4/ Y1/ Y2/ R3
The eligible participants in the Sequence (R4/ Y1/ Y2/ R3), received single oral dose of R4, where the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state, during Period 1, this was followed by the Y1 dose where the participants were administered a single oral dose of FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose during Period 2, this was followed by single oral dose of Y2 where the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose during Period 3, this was followed by a single oral dose of R3 dose where participants were administered a single oral dose of the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state, during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, Period 1 (up to 6 Days)
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Period 1 (up to 6 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Washout Period 1 (7 Days)
Protocol defined stop criteria reached
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Period 2 (up to 6 Days)
Protocol defined stop criteria reached
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Washout Period 3 (7 Days)
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2, Period 1 (up to 6 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3A, Period 1 (up to 6 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3B, Period 3 (up to 6 Days)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 3B, Washout Period 3 (10 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Part 3B, Washout Period 3 (10 Days)
Study terminated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Part 1
n=26 Participants
In Part 1, there were 5 dosing sessions of four formulations of the FDCs (ambrisentan 10 mg + tadalafil 40 mg) (F1, F2, F3, F4) and 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg (R) which were administered concurrently . The participants received a single oral dose of formulation or the reference during each session. All the doses were taken in fasted condition. The treatment period for Part 1 was of 4-weeks, post which there was a follow-up period of 14 days (which included 7-days washout)
|
Part 2
n=21 Participants
This comprised of 4 dose sessions, of 3 different granulation sizes for a single FDC (ambrisentan 10 mg +tadalafil 40 mg) compared to the reference of the 2 monotherapy components taken concurrently (ambrisentan 10 mg \& tadalafil 40 mg), to evaluate the bioavailability. This part of the study provided data for 3 granulation size forms of a single FDC formulation selected from Part 1. The participants received a single oral dose during each session. All the doses were taken in fasted condition. The treatment period for Part 2 was of 4-weeks, post which a follow-up period of 14 days (which included 7-days washout). Part 2 had FG1, FG2, FG3 which are Ambrisentan and Tadalafil FDCs (10mg/40mg). R is ambrisentan and tadalafil monotherapies taken concurrently (10mg/40mg).
|
Part 3A
n=33 Participants
This comprised of 4 dose sessions of the FDC against the reference ambrisentan 10 mg + tadalafil 40mg monotherapies in the fed and fasted state, taken to evaluate the bioequivalence. The participants received a single oral dose during each session, taken under fed and fasted conditions. The fed arms of this part of the study received a standard high fat breakfast. The treatment period of Part 3A was of 4-weeks, post which a follow-up period of 14 days (which included 10-days washout). In Part 3A, X1, X2 are ambrisentan and tadalafil FDCs (10mg/40mg),where X1 is under fed state and X2 is under fasted state. R1, R2 are Ambrisentan and Tadalafil monotherapies taken concurrently(10mg/40mg), where R1 is under fed state and R2 is under fasted state.
|
Part 3B
n=32 Participants
This study part comprised of 4 dose sessions which assessed the bioequivalence of the two FDC dose strengths, (ambrisentan 5 mg + tadalafil 40mg and ambrisentan 5 mg + tadalafil 20mg) against the reference ambrisentan 5 mg + tadalafil 40mg monotherapies and ambrisentan 5 mg + tadalafil 20mg monotherapies in the fasted state. The treatment period of Part 3B was of 4-weeks, post which there was a follow-up period of 14 days (which included 10-days washout). In the Part 3B, Y1, Y2 are ambrisentan and tadalafil FDCs, under fasted state, where Y1 is 5mg/40mg and Y2 is 5mg/20mg and R3, R4 are ambrisentan and tadalafil monotherapies taken concurrently, under fasted state, where R3 is 5mg/40mg and R4 is 5mg/20mg.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.7 Years
STANDARD_DEVIATION 11.68 • n=5 Participants
|
36.8 Years
STANDARD_DEVIATION 12.07 • n=7 Participants
|
37.3 Years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
30.9 Years
STANDARD_DEVIATION 12.05 • n=4 Participants
|
35.5 Years
STANDARD_DEVIATION 11.71 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
111 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · Asian-Central/South Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · Asian- South East Asian heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · Black Or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · White - Arabic/North African Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · White/Caucasian/European Heritage
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · Multiple-Asian and White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter Population
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time points for analysis of ambrisentan and tadafil. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 1 of the study. The analysis was performed on Pharmacokinetic (PK) parameter population, which included all participants who provided PK parameter data.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=23 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=23 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=22 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1
Ambrisentan, Cmax
|
685.33 Nanogram per milliliter
Geometric Coefficient of Variation 20.5
|
766.29 Nanogram per milliliter
Geometric Coefficient of Variation 18.2
|
738.49 Nanogram per milliliter
Geometric Coefficient of Variation 22.1
|
722.57 Nanogram per milliliter
Geometric Coefficient of Variation 27.7
|
755.37 Nanogram per milliliter
Geometric Coefficient of Variation 28.9
|
|
Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1
Tadalafil, Cmax
|
595.47 Nanogram per milliliter
Geometric Coefficient of Variation 22.3
|
581.41 Nanogram per milliliter
Geometric Coefficient of Variation 27.6
|
588.11 Nanogram per milliliter
Geometric Coefficient of Variation 24.5
|
590.36 Nanogram per milliliter
Geometric Coefficient of Variation 21.4
|
567.62 Nanogram per milliliter
Geometric Coefficient of Variation 18.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter Population
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples were collected at the indicated time-points. The analysis was done under fasting condition post single dose. There is no formal hypothesis tested for Part 1 of the study.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=23 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=23 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=22 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1
Ambrisentan, (AUC 0 - inf)
|
5556.44 Hour*nanogram per milliliter
Geometric Coefficient of Variation 25.9
|
5566.06 Hour*nanogram per milliliter
Geometric Coefficient of Variation 23.8
|
5788.91 Hour*nanogram per milliliter
Geometric Coefficient of Variation 25.8
|
6007.57 Hour*nanogram per milliliter
Geometric Coefficient of Variation 23.7
|
5746.73 Hour*nanogram per milliliter
Geometric Coefficient of Variation 20.8
|
|
Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1
Tadalafil, (AUC 0 - inf)
|
14415.47 Hour*nanogram per milliliter
Geometric Coefficient of Variation 41.8
|
13408.30 Hour*nanogram per milliliter
Geometric Coefficient of Variation 41.3
|
14545.28 Hour*nanogram per milliliter
Geometric Coefficient of Variation 38.4
|
14418.35 Hour*nanogram per milliliter
Geometric Coefficient of Variation 37.8
|
13955.85 Hour*nanogram per milliliter
Geometric Coefficient of Variation 36.2
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK Parameter Population
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples at Part 1, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours. The analysis was done under fasting condition post single dose. The PK Parameter Population was used for analysis. There is no formal hypotheses tested for Part 1 of the study.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=23 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=23 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=22 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1
Tadalafil, (AUC 0- t)
|
13307.95 Hour*nanogram per milliliter
Geometric Coefficient of Variation 37.4
|
12469.86 Hour*nanogram per milliliter
Geometric Coefficient of Variation 37.1
|
13376.86 Hour*nanogram per milliliter
Geometric Coefficient of Variation 34.8
|
13238.89 Hour*nanogram per milliliter
Geometric Coefficient of Variation 33.4
|
12805.01 Hour*nanogram per milliliter
Geometric Coefficient of Variation 32.2
|
|
AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1
Ambrisentan, (AUC 0- t)
|
5434.88 Hour*nanogram per milliliter
Geometric Coefficient of Variation 25.3
|
5418.03 Hour*nanogram per milliliter
Geometric Coefficient of Variation 22.9
|
5655.75 Hour*nanogram per milliliter
Geometric Coefficient of Variation 25.5
|
5858.18 Hour*nanogram per milliliter
Geometric Coefficient of Variation 22.9
|
5605.58 Hour*nanogram per milliliter
Geometric Coefficient of Variation 20.2
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter Population
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time-points, of Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2
Ambrisentan, (n=21,20,20,20)
|
720.79 Nanogram per milliliter
Geometric Coefficient of Variation 21.1
|
710.90 Nanogram per milliliter
Geometric Coefficient of Variation 28.2
|
748.63 Nanogram per milliliter
Geometric Coefficient of Variation 22.9
|
726.15 Nanogram per milliliter
Geometric Coefficient of Variation 31.4
|
—
|
|
Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2
Tadalafil, (n=20,20,20,20)
|
561.60 Nanogram per milliliter
Geometric Coefficient of Variation 28.4
|
537.80 Nanogram per milliliter
Geometric Coefficient of Variation 27.6
|
550.78 Nanogram per milliliter
Geometric Coefficient of Variation 28.6
|
553.31 Nanogram per milliliter
Geometric Coefficient of Variation 20.5
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter Population
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 2, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis, was done under fasting condition post single dose. PK parameter Populatio was used for analysis. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2
Tadalafil, AUC ( 0 - inf) (n=20,20,20,20)
|
14443.86 Hour*nanogram per milliliter
Geometric Coefficient of Variation 44.8
|
14006.59 Hour*nanogram per milliliter
Geometric Coefficient of Variation 46.7
|
14502.37 Hour*nanogram per milliliter
Geometric Coefficient of Variation 40.5
|
14457.33 Hour*nanogram per milliliter
Geometric Coefficient of Variation 40.5
|
—
|
|
AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2
Ambrisentan, AUC (0-inf) (n=21,20,20,20)
|
6179.41 Hour*nanogram per milliliter
Geometric Coefficient of Variation 27.2
|
6029.19 Hour*nanogram per milliliter
Geometric Coefficient of Variation 29.6
|
6189.22 Hour*nanogram per milliliter
Geometric Coefficient of Variation 29.5
|
6201.40 Hour*nanogram per milliliter
Geometric Coefficient of Variation 25.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter Population
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 2, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours. The analysis was done under fasting condition post single dose. PK parameter Population was used for analysis. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2
Tadalafil, (n=20,20,20,20)
|
13149.19 Hour*nanogram per milliliter
Geometric Coefficient of Variation 37.5
|
12832.91 Hour*nanogram per milliliter
Geometric Coefficient of Variation 39.6
|
13305.50 Hour*nanogram per milliliter
Geometric Coefficient of Variation 35.2
|
13275.08 Hour*nanogram per milliliter
Geometric Coefficient of Variation 33.3
|
—
|
|
AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2
Ambrisentan, (n=21,20,20,20)
|
6016.62 Hour*nanogram per milliliter
Geometric Coefficient of Variation 27.1
|
5893.74 Hour*nanogram per milliliter
Geometric Coefficient of Variation 29.4
|
6051.83 Hour*nanogram per milliliter
Geometric Coefficient of Variation 29.6
|
6015.11 Hour*nanogram per milliliter
Geometric Coefficient of Variation 25.9
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK Parameter Population
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fed and fasting condition post single dose. PK parameter population was used.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A
Tadalafil, Cmax
|
508.72 Nanogram per milliliter
Geometric Coefficient of Variation 24.9
|
525.10 Nanogram per milliliter
Geometric Coefficient of Variation 26.5
|
533.67 Nanogram per milliliter
Geometric Coefficient of Variation 19.5
|
520.62 Nanogram per milliliter
Geometric Coefficient of Variation 21.1
|
—
|
|
Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A
Ambrisentan, Cmax
|
756.60 Nanogram per milliliter
Geometric Coefficient of Variation 24.1
|
550.02 Nanogram per milliliter
Geometric Coefficient of Variation 30.9
|
515.61 Nanogram per milliliter
Geometric Coefficient of Variation 33.4
|
728.32 Nanogram per milliliter
Geometric Coefficient of Variation 29.8
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK Parameter Population.
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48 and 72 hours post-dose. The analysis, was done under fed and fasting conditions post single dose. PK parameter population was used.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A
Ambrisentan, AUC (0-inf)
|
6231.48 Hour*nanogram per milliliter
Geometric Coefficient of Variation 25.1
|
6075.51 Hour*nanogram per milliliter
Geometric Coefficient of Variation 26.1
|
5898.72 Hour*nanogram per milliliter
Geometric Coefficient of Variation 27.7
|
6155.60 Hour*nanogram per milliliter
Geometric Coefficient of Variation 24.4
|
—
|
|
AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A
Tadalafil, AUC (0-inf)
|
14856.32 Hour*nanogram per milliliter
Geometric Coefficient of Variation 40.0
|
16086.66 Hour*nanogram per milliliter
Geometric Coefficient of Variation 41.5
|
16596.18 Hour*nanogram per milliliter
Geometric Coefficient of Variation 37.8
|
14612.84 Hour*nanogram per milliliter
Geometric Coefficient of Variation 41.5
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK Parameter Population
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fed and fasting condition post single dose. PK parameter population was used.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A
Ambrisentan, AUC (0-t)
|
6090.74 Hour*nanogram per milliliter
Geometric Coefficient of Variation 24.8
|
5926.87 Hour*nanogram per milliliter
Geometric Coefficient of Variation 25.7
|
5766.71 Hour*nanogram per milliliter
Geometric Coefficient of Variation 27.4
|
6012.51 Hour*nanogram per milliliter
Geometric Coefficient of Variation 24.0
|
—
|
|
AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A
Tadalafil, AUC (0-t)
|
13320.79 Hour*nanogram per milliliter
Geometric Coefficient of Variation 32.4
|
14366.73 Hour*nanogram per milliliter
Geometric Coefficient of Variation 33.7
|
14946.32 Hour*nanogram per milliliter
Geometric Coefficient of Variation 31.1
|
13114.00 Hour*nanogram per milliliter
Geometric Coefficient of Variation 32.6
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK Parameter Population
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B
Ambrisentan, Cmax
|
380.47 Nanogram per milliliter
Geometric Coefficient of Variation 26.2
|
375.87 Nanogram per milliliter
Geometric Coefficient of Variation 23.0
|
—
|
—
|
—
|
|
Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B
Tadalafil, Cmax
|
511.80 Nanogram per milliliter
Geometric Coefficient of Variation 28.3
|
488.36 Nanogram per milliliter
Geometric Coefficient of Variation 19.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK Parameter Population
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36,48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK Parameter Population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B
Ambrisentan AUC (0-inf)
|
3277.81 Hour nanogram per milliliter
Geometric Coefficient of Variation 20.8
|
3397.51 Hour nanogram per milliliter
Geometric Coefficient of Variation 19.7
|
—
|
—
|
—
|
|
AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B
Tadalafil, AUC (0-inf)
|
14938.29 Hour nanogram per milliliter
Geometric Coefficient of Variation 40.7
|
14724.34 Hour nanogram per milliliter
Geometric Coefficient of Variation 39.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter population
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B
Tadalafil, AUC (0-t)
|
13325.63 Hour*nanogram per milliliter
Geometric Coefficient of Variation 35.0
|
13119.89 Hour*nanogram per milliliter
Geometric Coefficient of Variation 31.0
|
—
|
—
|
—
|
|
AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B
Ambrisentan, AUC (0-t)
|
3190.51 Hour*nanogram per milliliter
Geometric Coefficient of Variation 20.3
|
3297.16 Hour*nanogram per milliliter
Geometric Coefficient of Variation 19.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter population
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=30 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=31 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B
Tadalafil, Cmax
|
303.74 Nanogram per milliliter
Geometric Coefficient of Variation 22.5
|
340.63 Nanogram per milliliter
Geometric Coefficient of Variation 23.1
|
—
|
—
|
—
|
|
Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B
Ambrisentan, Cmax
|
358.89 Nanogram per milliliter
Geometric Coefficient of Variation 24.5
|
405.89 Nanogram per milliliter
Geometric Coefficient of Variation 25.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK Parameter Population.
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis, was done under fasting conditions post single dose. PK parameter population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=30 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=31 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B
Ambrisentan AUC (0-inf)
|
3205.51 Hour*nanogram per milliliter
Geometric Coefficient of Variation 20.6
|
3347.76 Hour*nanogram per milliliter
Geometric Coefficient of Variation 20.9
|
—
|
—
|
—
|
|
AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B
Tadalafil, AUC (0-inf)
|
7748.47 Hour*nanogram per milliliter
Geometric Coefficient of Variation 32.6
|
7962.14 Hour*nanogram per milliliter
Geometric Coefficient of Variation 32.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter population
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=30 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=31 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions- Part 3B
Tadalafil, AUC (0-t)
|
7076.48 Hour*nanogram per milliliter
Geometric Coefficient of Variation 27.4
|
7264.28 Hour*nanogram per milliliter
Geometric Coefficient of Variation 26.6
|
—
|
—
|
—
|
|
AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions- Part 3B
Ambrisentan AUC (0-t)
|
3116.10 Hour*nanogram per milliliter
Geometric Coefficient of Variation 20.3
|
3254.70 Hour*nanogram per milliliter
Geometric Coefficient of Variation 21.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter Population.
Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=23 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=23 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=22 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1
Ambrisentan, Tmax
|
1.500 Hour
Interval 0.53 to 4.0
|
1.000 Hour
Interval 0.5 to 8.23
|
1.500 Hour
Interval 0.52 to 4.0
|
1.500 Hour
Interval 0.57 to 4.05
|
1.500 Hour
Interval 0.5 to 4.0
|
|
Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1
Tadafil, Tmax
|
2.000 Hour
Interval 0.5 to 8.03
|
1.500 Hour
Interval 0.5 to 8.23
|
2.000 Hour
Interval 0.5 to 8.0
|
2.000 Hour
Interval 0.5 to 8.0
|
1.500 Hour
Interval 0.5 to 4.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter population.
Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2
Ambrisentan, Tmax (n=21,20,20,20)
|
1.500 hour
Interval 0.5 to 4.0
|
1.500 hour
Interval 0.5 to 4.03
|
1.500 hour
Interval 0.5 to 4.0
|
1.508 hour
Interval 1.0 to 8.0
|
—
|
|
Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2
Tadafil, Tmax (n=20,20,20,20)
|
1.750 hour
Interval 0.5 to 8.08
|
2.017 hour
Interval 0.5 to 8.02
|
2.000 hour
Interval 0.5 to 8.0
|
2.000 hour
Interval 0.5 to 12.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter Population.
Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A
Ambrisentan, Tmax
|
1.500 Hour
Interval 0.5 to 4.0
|
4.00 Hour
Interval 1.0 to 12.0
|
4.00 Hour
Interval 1.0 to 12.15
|
2.000 Hour
Interval 1.0 to 4.0
|
—
|
|
Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A
Tadafil, Tmax
|
2.500 Hour
Interval 0.5 to 12.02
|
8.000 Hour
Interval 0.5 to 12.02
|
8.000 Hour
Interval 1.5 to 12.15
|
2.258 Hour
Interval 0.5 to 8.03
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter Population.
Serial blood samples were collected at the indicated time-points. In Part 3B, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=31 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=30 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B
Ambrisentan, Tmax
|
1.500 Hour
Interval 1.0 to 8.0
|
1.767 Hour
Interval 1.0 to 4.03
|
2.000 Hour
Interval 1.0 to 8.0
|
1.758 Hour
Interval 1.0 to 8.0
|
—
|
|
Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B
Tadafil, Tmax
|
1.500 Hour
Interval 0.5 to 8.0
|
2.500 Hour
Interval 0.5 to 8.0
|
2.500 Hour
Interval 0.5 to 8.0
|
2.008 Hour
Interval 0.5 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter Population.
t1/2 is defined as the time required by the concentration of the drug to reach half of its original value.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=23 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=23 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=22 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1
Ambrisentan, t1/2
|
15.25 Hour
Geometric Coefficient of Variation 19.2
|
16.74 Hour
Geometric Coefficient of Variation 18.2
|
15.76 Hour
Geometric Coefficient of Variation 17.3
|
15.25 Hour
Geometric Coefficient of Variation 20.0
|
16.08 Hour
Geometric Coefficient of Variation 17.9
|
|
Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1
Tadalafil, t1/2
|
17.76 Hour
Geometric Coefficient of Variation 33.3
|
17.08 Hour
Geometric Coefficient of Variation 30.4
|
18.38 Hour
Geometric Coefficient of Variation 33.3
|
18.48 Hour
Geometric Coefficient of Variation 33.0
|
18.04 Hour
Geometric Coefficient of Variation 30.4
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter Population.
t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2
Tadalafil, t1/2, (n=20,20,20,20)
|
18.63 Hour
Geometric Coefficient of Variation 33.2
|
18.58 Hour
Geometric Coefficient of Variation 30.6
|
18.22 Hour
Geometric Coefficient of Variation 33.2
|
17.98 Hour
Geometric Coefficient of Variation 32.6
|
—
|
|
Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2
Ambrisentan, t1/2 (n=21,20,20,20)
|
15.76 Hour
Geometric Coefficient of Variation 33.3
|
15.19 Hour
Geometric Coefficient of Variation 24.5
|
15.39 Hour
Geometric Coefficient of Variation 18.6
|
16.60 Hour
Geometric Coefficient of Variation 34.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dosePopulation: PK parameter population
t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. The serial blood samples were assessed at specified timepoints.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A
Ambrisentan, t1/2
|
15.42 Hour
Geometric Coefficient of Variation 15.9
|
15.65 Hour
Geometric Coefficient of Variation 16.7
|
14.66 Hour
Geometric Coefficient of Variation 13.7
|
15.63 Hour
Geometric Coefficient of Variation 16.6
|
—
|
|
Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A
Tadalafil, t1/2
|
19.85 Hour
Geometric Coefficient of Variation 34.2
|
20.09 Hour
Geometric Coefficient of Variation 34.4
|
19.29 Hour
Geometric Coefficient of Variation 33.4
|
19.86 Hour
Geometric Coefficient of Variation 36.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48, and 72 hours postdosePopulation: PK parameter Population.
t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. The serial blood samples were assessed at specified timepoints.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=31 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=30 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B
Tadalafil, t1/2
|
19.01 Hour
Geometric Coefficient of Variation 31.1
|
20.27 Hour
Geometric Coefficient of Variation 34.3
|
20.34 Hour
Geometric Coefficient of Variation 34.4
|
18.95 Hour
Geometric Coefficient of Variation 30.8
|
—
|
|
Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B
Ambrisentan, t1/2
|
16.42 Hour
Geometric Coefficient of Variation 17.1
|
16.39 Hour
Geometric Coefficient of Variation 21.6
|
16.15 Hour
Geometric Coefficient of Variation 18.7
|
16.00 Hour
Geometric Coefficient of Variation 19.7
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=23 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=23 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=22 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
DBP, 0.5 hour
|
-3.54 Milliliters of Mercury
Standard Deviation 4.164
|
-3.33 Milliliters of Mercury
Standard Deviation 6.626
|
-4.20 Milliliters of Mercury
Standard Deviation 5.622
|
-2.86 Milliliters of Mercury
Standard Deviation 5.330
|
-2.79 Milliliters of Mercury
Standard Deviation 7.737
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
DBP, 1 hour
|
-4.72 Milliliters of Mercury
Standard Deviation 4.008
|
-5.33 Milliliters of Mercury
Standard Deviation 6.516
|
-5.63 Milliliters of Mercury
Standard Deviation 3.938
|
-5.73 Milliliters of Mercury
Standard Deviation 6.001
|
-4.40 Milliliters of Mercury
Standard Deviation 4.705
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
DBP, 2 hour
|
-5.28 Milliliters of Mercury
Standard Deviation 5.220
|
-5.24 Milliliters of Mercury
Standard Deviation 7.118
|
-5.98 Milliliters of Mercury
Standard Deviation 3.632
|
-7.27 Milliliters of Mercury
Standard Deviation 5.101
|
-5.83 Milliliters of Mercury
Standard Deviation 4.856
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
DBP, 12 hour
|
-6.16 Milliliters of Mercury
Standard Deviation 5.685
|
-4.76 Milliliters of Mercury
Standard Deviation 7.604
|
-5.72 Milliliters of Mercury
Standard Deviation 5.994
|
-8.18 Milliliters of Mercury
Standard Deviation 8.296
|
-5.60 Milliliters of Mercury
Standard Deviation 7.687
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
SBP, 2 hour
|
-5.39 Milliliters of Mercury
Standard Deviation 7.116
|
-6.05 Milliliters of Mercury
Standard Deviation 9.822
|
-3.11 Milliliters of Mercury
Standard Deviation 6.098
|
-6.91 Milliliters of Mercury
Standard Deviation 9.148
|
-5.40 Milliliters of Mercury
Standard Deviation 4.543
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
DBP, 4 hour
|
-5.72 Milliliters of Mercury
Standard Deviation 4.064
|
-4.29 Milliliters of Mercury
Standard Deviation 5.205
|
-6.07 Milliliters of Mercury
Standard Deviation 6.031
|
-7.09 Milliliters of Mercury
Standard Deviation 5.149
|
-5.21 Milliliters of Mercury
Standard Deviation 6.059
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
DBP, 8 hour
|
-6.67 Milliliters of Mercury
Standard Deviation 6.704
|
-9.10 Milliliters of Mercury
Standard Deviation 9.963
|
-6.50 Milliliters of Mercury
Standard Deviation 5.610
|
-9.68 Milliliters of Mercury
Standard Deviation 6.263
|
-7.83 Milliliters of Mercury
Standard Deviation 6.487
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
DBP, 24 hour
|
-4.50 Milliliters of Mercury
Standard Deviation 6.308
|
-5.86 Milliliters of Mercury
Standard Deviation 7.004
|
-4.07 Milliliters of Mercury
Standard Deviation 5.792
|
-5.59 Milliliters of Mercury
Standard Deviation 6.235
|
-3.55 Milliliters of Mercury
Standard Deviation 5.987
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
DBP, 48 hour
|
-1.02 Milliliters of Mercury
Standard Deviation 6.091
|
-2.38 Milliliters of Mercury
Standard Deviation 5.232
|
-4.02 Milliliters of Mercury
Standard Deviation 6.589
|
-4.18 Milliliters of Mercury
Standard Deviation 4.382
|
-0.74 Milliliters of Mercury
Standard Deviation 6.644
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
DBP, 72 hour
|
-0.67 Milliliters of Mercury
Standard Deviation 5.676
|
0.76 Milliliters of Mercury
Standard Deviation 5.845
|
0.20 Milliliters of Mercury
Standard Deviation 7.371
|
-1.73 Milliliters of Mercury
Standard Deviation 5.311
|
-0.15 Milliliters of Mercury
Standard Deviation 6.556
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
SBP, 0.5 hour
|
-3.22 Milliliters of Mercury
Standard Deviation 8.590
|
-1.10 Milliliters of Mercury
Standard Deviation 7.521
|
-1.59 Milliliters of Mercury
Standard Deviation 5.441
|
-3.68 Milliliters of Mercury
Standard Deviation 6.438
|
-3.36 Milliliters of Mercury
Standard Deviation 4.953
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
SBP, 1 hour
|
-4.13 Milliliters of Mercury
Standard Deviation 7.091
|
-2.76 Milliliters of Mercury
Standard Deviation 8.153
|
-2.54 Milliliters of Mercury
Standard Deviation 7.662
|
-6.00 Milliliters of Mercury
Standard Deviation 7.624
|
-3.74 Milliliters of Mercury
Standard Deviation 6.549
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
SBP, 4 hour
|
-7.30 Milliliters of Mercury
Standard Deviation 8.244
|
-3.90 Milliliters of Mercury
Standard Deviation 7.143
|
-5.50 Milliliters of Mercury
Standard Deviation 5.671
|
-6.59 Milliliters of Mercury
Standard Deviation 7.699
|
-5.36 Milliliters of Mercury
Standard Deviation 7.892
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
SBP, 8 hour
|
-5.48 Milliliters of Mercury
Standard Deviation 9.279
|
-6.10 Milliliters of Mercury
Standard Deviation 8.770
|
-4.02 Milliliters of Mercury
Standard Deviation 7.346
|
-10.55 Milliliters of Mercury
Standard Deviation 9.579
|
-8.40 Milliliters of Mercury
Standard Deviation 8.434
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
SBP, 12 hour
|
-0.84 Milliliters of Mercury
Standard Deviation 9.278
|
0.14 Milliliters of Mercury
Standard Deviation 8.755
|
0.54 Milliliters of Mercury
Standard Deviation 9.720
|
-4.77 Milliliters of Mercury
Standard Deviation 12.023
|
-3.60 Milliliters of Mercury
Standard Deviation 8.185
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
SBP, 24 hour
|
-3.17 Milliliters of Mercury
Standard Deviation 9.767
|
-1.48 Milliliters of Mercury
Standard Deviation 6.541
|
0.02 Milliliters of Mercury
Standard Deviation 7.770
|
-3.82 Milliliters of Mercury
Standard Deviation 7.276
|
-1.79 Milliliters of Mercury
Standard Deviation 6.758
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
SBP, 48 hour
|
2.39 Milliliters of Mercury
Standard Deviation 7.010
|
1.52 Milliliters of Mercury
Standard Deviation 9.052
|
2.50 Milliliters of Mercury
Standard Deviation 8.577
|
-0.64 Milliliters of Mercury
Standard Deviation 7.315
|
-0.31 Milliliters of Mercury
Standard Deviation 8.710
|
|
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
SBP, 72 hour
|
3.52 Milliliters of Mercury
Standard Deviation 8.993
|
6.95 Milliliters of Mercury
Standard Deviation 7.048
|
3.37 Milliliters of Mercury
Standard Deviation 8.801
|
4.18 Milliliters of Mercury
Standard Deviation 7.341
|
3.00 Milliliters of Mercury
Standard Deviation 7.854
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population.
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs-Heart Rate, Part 1
HR, 0.5 hour
|
2.89 Beats per minute
Standard Deviation 2.558
|
2.98 Beats per minute
Standard Deviation 4.766
|
1.13 Beats per minute
Standard Deviation 3.181
|
2.98 Beats per minute
Standard Deviation 3.718
|
3.74 Beats per minute
Standard Deviation 4.024
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 1
HR, 1 hour
|
4.11 Beats per minute
Standard Deviation 2.620
|
3.79 Beats per minute
Standard Deviation 4.314
|
2.48 Beats per minute
Standard Deviation 4.981
|
3.30 Beats per minute
Standard Deviation 3.112
|
4.17 Beats per minute
Standard Deviation 4.223
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 1
HR, 2 hour
|
4.41 Beats per minute
Standard Deviation 3.107
|
3.69 Beats per minute
Standard Deviation 5.451
|
1.91 Beats per minute
Standard Deviation 4.562
|
2.48 Beats per minute
Standard Deviation 4.393
|
2.83 Beats per minute
Standard Deviation 4.127
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 1
HR, 4 hour
|
3.63 Beats per minute
Standard Deviation 3.331
|
3.26 Beats per minute
Standard Deviation 4.449
|
1.52 Beats per minute
Standard Deviation 4.636
|
3.16 Beats per minute
Standard Deviation 5.176
|
2.12 Beats per minute
Standard Deviation 3.584
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 1
HR, 8 hour
|
7.93 Beats per minute
Standard Deviation 5.407
|
8.26 Beats per minute
Standard Deviation 6.488
|
7.17 Beats per minute
Standard Deviation 6.583
|
6.11 Beats per minute
Standard Deviation 5.323
|
7.55 Beats per minute
Standard Deviation 5.522
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 1
HR, 12 hour
|
12.75 Beats per minute
Standard Deviation 6.141
|
10.40 Beats per minute
Standard Deviation 6.387
|
10.48 Beats per minute
Standard Deviation 7.264
|
11.11 Beats per minute
Standard Deviation 7.687
|
10.83 Beats per minute
Standard Deviation 5.342
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 1
HR, 24 hour
|
7.02 Beats per minute
Standard Deviation 6.343
|
6.17 Beats per minute
Standard Deviation 4.498
|
6.52 Beats per minute
Standard Deviation 5.371
|
5.61 Beats per minute
Standard Deviation 5.381
|
6.74 Beats per minute
Standard Deviation 7.915
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 1
HR, 48 hour
|
8.67 Beats per minute
Standard Deviation 6.539
|
9.21 Beats per minute
Standard Deviation 5.110
|
7.57 Beats per minute
Standard Deviation 5.623
|
6.48 Beats per minute
Standard Deviation 5.302
|
7.69 Beats per minute
Standard Deviation 5.501
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 1
HR, 72 hour
|
7.54 Beats per minute
Standard Deviation 7.762
|
6.21 Beats per minute
Standard Deviation 4.665
|
6.57 Beats per minute
Standard Deviation 7.789
|
5.57 Beats per minute
Standard Deviation 7.323
|
5.03 Beats per minute
Standard Deviation 6.014
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=23 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=23 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=22 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital- Temperature, Part 1
Temperature, 48 hour
|
0.18 Degree celsius
Standard Deviation 0.404
|
-0.01 Degree celsius
Standard Deviation 0.371
|
0.01 Degree celsius
Standard Deviation 0.393
|
0.05 Degree celsius
Standard Deviation 0.571
|
0.16 Degree celsius
Standard Deviation 0.508
|
|
Change From Baseline in Vital- Temperature, Part 1
Temperature, 72 hour
|
0.03 Degree celsius
Standard Deviation 0.503
|
0.12 Degree celsius
Standard Deviation 0.351
|
-0.02 Degree celsius
Standard Deviation 0.392
|
0.10 Degree celsius
Standard Deviation 0.424
|
0.02 Degree celsius
Standard Deviation 0.506
|
|
Change From Baseline in Vital- Temperature, Part 1
Temperature, 12 hour
|
0.16 Degree celsius
Standard Deviation 0.386
|
0.09 Degree celsius
Standard Deviation 0.371
|
-0.03 Degree celsius
Standard Deviation 0.438
|
0.08 Degree celsius
Standard Deviation 0.405
|
0.02 Degree celsius
Standard Deviation 0.597
|
|
Change From Baseline in Vital- Temperature, Part 1
Temperature, 24 hour
|
0.03 Degree celsius
Standard Deviation 0.328
|
-0.04 Degree celsius
Standard Deviation 0.273
|
0.14 Degree celsius
Standard Deviation 0.390
|
0.13 Degree celsius
Standard Deviation 0.413
|
0.07 Degree celsius
Standard Deviation 0.543
|
|
Change From Baseline in Vital- Temperature, Part 1
Temperature, 0.5 hour
|
-0.05 Degree celsius
Standard Deviation 0.250
|
-0.20 Degree celsius
Standard Deviation 0.220
|
-0.12 Degree celsius
Standard Deviation 0.233
|
-0.18 Degree celsius
Standard Deviation 0.357
|
-0.03 Degree celsius
Standard Deviation 0.201
|
|
Change From Baseline in Vital- Temperature, Part 1
Temperature, 1 hour
|
-0.09 Degree celsius
Standard Deviation 0.343
|
-0.15 Degree celsius
Standard Deviation 0.275
|
-0.07 Degree celsius
Standard Deviation 0.216
|
-0.06 Degree celsius
Standard Deviation 0.426
|
-0.12 Degree celsius
Standard Deviation 0.386
|
|
Change From Baseline in Vital- Temperature, Part 1
Temperature, 2 hour
|
-0.16 Degree celsius
Standard Deviation 0.383
|
-0.14 Degree celsius
Standard Deviation 0.271
|
-0.23 Degree celsius
Standard Deviation 0.392
|
-0.04 Degree celsius
Standard Deviation 0.473
|
-0.14 Degree celsius
Standard Deviation 0.393
|
|
Change From Baseline in Vital- Temperature, Part 1
Temperature, 4 hour
|
-0.08 Degree celsius
Standard Deviation 0.326
|
-0.28 Degree celsius
Standard Deviation 0.363
|
-0.17 Degree celsius
Standard Deviation 0.328
|
-0.03 Degree celsius
Standard Deviation 0.331
|
-0.10 Degree celsius
Standard Deviation 0.381
|
|
Change From Baseline in Vital- Temperature, Part 1
Temperature, 8 hour
|
0.03 Degree celsius
Standard Deviation 0.438
|
-0.04 Degree celsius
Standard Deviation 0.460
|
-0.08 Degree celsius
Standard Deviation 0.400
|
0.08 Degree celsius
Standard Deviation 0.422
|
0.02 Degree celsius
Standard Deviation 0.408
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population.
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 1
Respiratory rate, 0.5 hour
|
-0.7 Breaths per minute
Standard Deviation 2.38
|
-0.5 Breaths per minute
Standard Deviation 2.23
|
-0.1 Breaths per minute
Standard Deviation 3.17
|
0.3 Breaths per minute
Standard Deviation 1.88
|
1.1 Breaths per minute
Standard Deviation 1.49
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 1
Respiratory rate, 1 hour
|
-1.0 Breaths per minute
Standard Deviation 2.69
|
-0.5 Breaths per minute
Standard Deviation 2.62
|
0.0 Breaths per minute
Standard Deviation 2.76
|
0.6 Breaths per minute
Standard Deviation 2.72
|
0.6 Breaths per minute
Standard Deviation 2.11
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 1
Respiratory rate, 4 hour
|
-0.8 Breaths per minute
Standard Deviation 1.98
|
-1.0 Breaths per minute
Standard Deviation 2.10
|
-0.5 Breaths per minute
Standard Deviation 2.91
|
0.2 Breaths per minute
Standard Deviation 2.54
|
0.4 Breaths per minute
Standard Deviation 2.42
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 1
Respiratory rate, 8 hour
|
0.2 Breaths per minute
Standard Deviation 2.33
|
0.1 Breaths per minute
Standard Deviation 2.73
|
0.0 Breaths per minute
Standard Deviation 2.63
|
0.6 Breaths per minute
Standard Deviation 2.42
|
0.6 Breaths per minute
Standard Deviation 2.20
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 1
Respiratory rate, 24 hour
|
-0.7 Breaths per minute
Standard Deviation 2.22
|
-0.5 Breaths per minute
Standard Deviation 2.44
|
-0.4 Breaths per minute
Standard Deviation 2.63
|
-0.1 Breaths per minute
Standard Deviation 2.35
|
1.0 Breaths per minute
Standard Deviation 3.20
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 1
Respiratory rate, 48 hour
|
-0.6 Breaths per minute
Standard Deviation 2.52
|
0.2 Breaths per minute
Standard Deviation 2.68
|
0.4 Breaths per minute
Standard Deviation 3.07
|
-0.0 Breaths per minute
Standard Deviation 2.55
|
0.3 Breaths per minute
Standard Deviation 3.86
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 1
Respiratory rate, 72 hour
|
-0.1 Breaths per minute
Standard Deviation 3.38
|
-0.8 Breaths per minute
Standard Deviation 2.44
|
0.7 Breaths per minute
Standard Deviation 3.17
|
1.0 Breaths per minute
Standard Deviation 2.60
|
0.8 Breaths per minute
Standard Deviation 2.46
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 1
Respiratory rate, 2 hour
|
-1.0 Breaths per minute
Standard Deviation 2.08
|
-0.0 Breaths per minute
Standard Deviation 1.56
|
-0.2 Breaths per minute
Standard Deviation 2.55
|
0.4 Breaths per minute
Standard Deviation 2.48
|
0.5 Breaths per minute
Standard Deviation 2.44
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 1
Respiratory rate, 12 hour
|
0.4 Breaths per minute
Standard Deviation 1.81
|
0.5 Breaths per minute
Standard Deviation 2.86
|
0.3 Breaths per minute
Standard Deviation 2.93
|
0.9 Breaths per minute
Standard Deviation 2.94
|
1.7 Breaths per minute
Standard Deviation 3.30
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital- SBP and DBP, Part 2
DBP, 2 hour
|
-4.98 Milliliters of Mercury
Standard Deviation 5.488
|
-5.67 Milliliters of Mercury
Standard Deviation 7.073
|
-5.85 Milliliters of Mercury
Standard Deviation 5.974
|
-7.05 Milliliters of Mercury
Standard Deviation 5.954
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
DBP, 12 hour
|
-3.18 Milliliters of Mercury
Standard Deviation 5.669
|
-3.76 Milliliters of Mercury
Standard Deviation 7.800
|
-2.25 Milliliters of Mercury
Standard Deviation 6.084
|
-4.35 Milliliters of Mercury
Standard Deviation 5.912
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
DBP, 24 hour
|
-1.03 Milliliters of Mercury
Standard Deviation 6.791
|
-3.00 Milliliters of Mercury
Standard Deviation 7.342
|
-2.00 Milliliters of Mercury
Standard Deviation 6.318
|
-5.25 Milliliters of Mercury
Standard Deviation 6.470
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
DBP, 48 hour
|
2.48 Milliliters of Mercury
Standard Deviation 6.451
|
-3.29 Milliliters of Mercury
Standard Deviation 7.125
|
1.35 Milliliters of Mercury
Standard Deviation 5.956
|
1.40 Milliliters of Mercury
Standard Deviation 4.901
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
DBP, 72 hour
|
3.23 Milliliters of Mercury
Standard Deviation 5.357
|
0.95 Milliliters of Mercury
Standard Deviation 8.399
|
2.05 Milliliters of Mercury
Standard Deviation 6.671
|
1.50 Milliliters of Mercury
Standard Deviation 6.907
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
SBP, 0.5 hour
|
1.63 Milliliters of Mercury
Standard Deviation 5.314
|
-1.57 Milliliters of Mercury
Standard Deviation 5.388
|
2.90 Milliliters of Mercury
Standard Deviation 4.576
|
-0.33 Milliliters of Mercury
Standard Deviation 4.913
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
SBP, 1 hour
|
-3.93 Milliliters of Mercury
Standard Deviation 6.057
|
-4.43 Milliliters of Mercury
Standard Deviation 8.996
|
-2.05 Milliliters of Mercury
Standard Deviation 8.000
|
-1.98 Milliliters of Mercury
Standard Deviation 7.144
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
SBP, 2 hour
|
-2.48 Milliliters of Mercury
Standard Deviation 5.683
|
-5.52 Milliliters of Mercury
Standard Deviation 8.848
|
-1.45 Milliliters of Mercury
Standard Deviation 7.112
|
-7.33 Milliliters of Mercury
Standard Deviation 9.574
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
SBP, 4 hour
|
-2.13 Milliliters of Mercury
Standard Deviation 6.456
|
-3.05 Milliliters of Mercury
Standard Deviation 7.561
|
-2.45 Milliliters of Mercury
Standard Deviation 7.082
|
-5.58 Milliliters of Mercury
Standard Deviation 6.053
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
SBP, 24 hour
|
-0.68 Milliliters of Mercury
Standard Deviation 8.307
|
-2.95 Milliliters of Mercury
Standard Deviation 7.847
|
-0.30 Milliliters of Mercury
Standard Deviation 8.163
|
-1.68 Milliliters of Mercury
Standard Deviation 6.218
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
DBP, 0.5 hour
|
0.28 Milliliters of Mercury
Standard Deviation 5.707
|
-2.29 Milliliters of Mercury
Standard Deviation 5.396
|
-0.25 Milliliters of Mercury
Standard Deviation 5.564
|
-1.00 Milliliters of Mercury
Standard Deviation 5.091
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
DBP, 1 hour
|
-4.23 Milliliters of Mercury
Standard Deviation 5.686
|
-4.71 Milliliters of Mercury
Standard Deviation 7.329
|
-4.55 Milliliters of Mercury
Standard Deviation 5.264
|
-4.35 Milliliters of Mercury
Standard Deviation 5.703
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
DBP, 4 hour
|
-3.53 Milliliters of Mercury
Standard Deviation 7.159
|
-4.10 Milliliters of Mercury
Standard Deviation 6.468
|
-3.90 Milliliters of Mercury
Standard Deviation 7.080
|
-5.10 Milliliters of Mercury
Standard Deviation 6.131
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
DBP, 8 hour
|
-2.58 Milliliters of Mercury
Standard Deviation 7.979
|
-4.43 Milliliters of Mercury
Standard Deviation 8.603
|
-5.15 Milliliters of Mercury
Standard Deviation 6.917
|
-5.65 Milliliters of Mercury
Standard Deviation 8.278
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
SBP, 8 hour
|
-3.98 Milliliters of Mercury
Standard Deviation 7.046
|
-5.43 Milliliters of Mercury
Standard Deviation 8.982
|
-2.35 Milliliters of Mercury
Standard Deviation 6.471
|
-6.38 Milliliters of Mercury
Standard Deviation 8.617
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
SBP, 12 hour
|
4.38 Milliliters of Mercury
Standard Deviation 9.418
|
-0.05 Milliliters of Mercury
Standard Deviation 7.292
|
2.00 Milliliters of Mercury
Standard Deviation 6.951
|
0.83 Milliliters of Mercury
Standard Deviation 6.822
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
SBP, 48 hour
|
4.78 Milliliters of Mercury
Standard Deviation 7.911
|
-2.00 Milliliters of Mercury
Standard Deviation 5.820
|
0.85 Milliliters of Mercury
Standard Deviation 8.570
|
2.08 Milliliters of Mercury
Standard Deviation 4.660
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 2
SBP, 72 hour
|
5.13 Milliliters of Mercury
Standard Deviation 7.609
|
4.14 Milliliters of Mercury
Standard Deviation 7.636
|
5.00 Milliliters of Mercury
Standard Deviation 6.345
|
3.48 Milliliters of Mercury
Standard Deviation 8.367
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population.
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs-Heart Rate, Part 2
HR, 0.5 hour
|
2.85 Beats per minute
Standard Deviation 4.934
|
1.45 Beats per minute
Standard Deviation 4.040
|
1.95 Beats per minute
Standard Deviation 6.219
|
2.20 Beats per minute
Standard Deviation 3.975
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 2
HR, 4 hour
|
5.45 Beats per minute
Standard Deviation 11.978
|
3.36 Beats per minute
Standard Deviation 5.287
|
3.20 Beats per minute
Standard Deviation 7.428
|
6.00 Beats per minute
Standard Deviation 5.978
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 2
HR, 24 hour
|
8.80 Beats per minute
Standard Deviation 6.031
|
6.74 Beats per minute
Standard Deviation 6.100
|
8.00 Beats per minute
Standard Deviation 7.395
|
8.70 Beats per minute
Standard Deviation 7.388
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 2
HR, 1 hour
|
3.85 Beats per minute
Standard Deviation 4.665
|
3.12 Beats per minute
Standard Deviation 4.475
|
5.10 Beats per minute
Standard Deviation 6.528
|
5.35 Beats per minute
Standard Deviation 3.208
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 2
HR, 2 hour
|
3.75 Beats per minute
Standard Deviation 6.568
|
3.21 Beats per minute
Standard Deviation 3.720
|
2.75 Beats per minute
Standard Deviation 5.959
|
6.45 Beats per minute
Standard Deviation 6.039
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 2
HR, 8 hour
|
8.30 Beats per minute
Standard Deviation 7.596
|
9.36 Beats per minute
Standard Deviation 7.720
|
6.55 Beats per minute
Standard Deviation 6.901
|
8.30 Beats per minute
Standard Deviation 9.234
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 2
HR, 12 hour
|
14.80 Beats per minute
Standard Deviation 9.512
|
17.21 Beats per minute
Standard Deviation 7.348
|
15.50 Beats per minute
Standard Deviation 6.473
|
16.45 Beats per minute
Standard Deviation 6.669
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 2
HR, 48 hour
|
5.70 Beats per minute
Standard Deviation 4.697
|
6.79 Beats per minute
Standard Deviation 5.361
|
5.10 Beats per minute
Standard Deviation 5.973
|
5.90 Beats per minute
Standard Deviation 4.599
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 2
HR, 72 hour
|
7.90 Beats per minute
Standard Deviation 8.534
|
9.40 Beats per minute
Standard Deviation 8.412
|
7.80 Beats per minute
Standard Deviation 8.427
|
9.30 Beats per minute
Standard Deviation 7.153
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital- Temperature, Part 2
Temperature, 0.5 hour
|
-0.02 Degree celsius
Standard Deviation 0.281
|
-0.07 Degree celsius
Standard Deviation 0.403
|
-0.05 Degree celsius
Standard Deviation 0.261
|
-0.14 Degree celsius
Standard Deviation 0.339
|
—
|
|
Change From Baseline in Vital- Temperature, Part 2
Temperature, 4 hour
|
-0.06 Degree celsius
Standard Deviation 0.366
|
-0.01 Degree celsius
Standard Deviation 0.348
|
0.03 Degree celsius
Standard Deviation 0.286
|
-0.19 Degree celsius
Standard Deviation 0.399
|
—
|
|
Change From Baseline in Vital- Temperature, Part 2
Temperature, 8 hour
|
-0.08 Degree celsius
Standard Deviation 0.375
|
0.02 Degree celsius
Standard Deviation 0.397
|
0.05 Degree celsius
Standard Deviation 0.343
|
0.03 Degree celsius
Standard Deviation 0.425
|
—
|
|
Change From Baseline in Vital- Temperature, Part 2
Temperature, 12 hour
|
0.04 Degree celsius
Standard Deviation 0.437
|
0.20 Degree celsius
Standard Deviation 0.409
|
0.09 Degree celsius
Standard Deviation 0.418
|
0.10 Degree celsius
Standard Deviation 0.494
|
—
|
|
Change From Baseline in Vital- Temperature, Part 2
Temperature, 24 hour
|
-0.02 Degree celsius
Standard Deviation 0.373
|
-0.06 Degree celsius
Standard Deviation 0.285
|
0.24 Degree celsius
Standard Deviation 0.298
|
0.07 Degree celsius
Standard Deviation 0.400
|
—
|
|
Change From Baseline in Vital- Temperature, Part 2
Temperature, 72 hour
|
-0.13 Degree celsius
Standard Deviation 0.490
|
-0.09 Degree celsius
Standard Deviation 0.435
|
0.05 Degree celsius
Standard Deviation 0.375
|
0.06 Degree celsius
Standard Deviation 0.366
|
—
|
|
Change From Baseline in Vital- Temperature, Part 2
Temperature, 1 hour
|
-0.11 Degree celsius
Standard Deviation 0.301
|
-0.13 Degree celsius
Standard Deviation 0.280
|
-0.01 Degree celsius
Standard Deviation 0.300
|
-0.04 Degree celsius
Standard Deviation 0.342
|
—
|
|
Change From Baseline in Vital- Temperature, Part 2
Temperature, 2 hour
|
-0.17 Degree celsius
Standard Deviation 0.279
|
-0.12 Degree celsius
Standard Deviation 0.349
|
-0.03 Degree celsius
Standard Deviation 0.310
|
-0.23 Degree celsius
Standard Deviation 0.397
|
—
|
|
Change From Baseline in Vital- Temperature, Part 2
Temperature, 48 hour
|
-0.06 Degree celsius
Standard Deviation 0.312
|
-0.06 Degree celsius
Standard Deviation 0.441
|
0.03 Degree celsius
Standard Deviation 0.353
|
-0.11 Degree celsius
Standard Deviation 0.488
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population.
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 2
Respiratory rate, 0.5 hour
|
-0.7 Breaths per minute
Standard Deviation 2.27
|
0.7 Breaths per minute
Standard Deviation 2.92
|
0.3 Breaths per minute
Standard Deviation 2.85
|
-1.1 Breaths per minute
Standard Deviation 2.04
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 2
Respiratory rate, 1 hour
|
-0.4 Breaths per minute
Standard Deviation 2.56
|
-0.9 Breaths per minute
Standard Deviation 2.15
|
0.3 Breaths per minute
Standard Deviation 2.70
|
-0.7 Breaths per minute
Standard Deviation 2.21
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 2
Respiratory rate, 2 hour
|
-1.2 Breaths per minute
Standard Deviation 2.86
|
-0.6 Breaths per minute
Standard Deviation 3.32
|
0.4 Breaths per minute
Standard Deviation 3.41
|
-1.1 Breaths per minute
Standard Deviation 2.70
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 2
Respiratory rate, 8 hour
|
0.5 Breaths per minute
Standard Deviation 2.82
|
0.1 Breaths per minute
Standard Deviation 3.00
|
0.4 Breaths per minute
Standard Deviation 2.37
|
-0.5 Breaths per minute
Standard Deviation 2.06
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 2
Respiratory rate, 24 hour
|
-0.3 Breaths per minute
Standard Deviation 2.92
|
-0.1 Breaths per minute
Standard Deviation 3.00
|
1.3 Breaths per minute
Standard Deviation 2.70
|
0.4 Breaths per minute
Standard Deviation 2.32
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 2
Respiratory rate, 72 hour
|
0.6 Breaths per minute
Standard Deviation 2.67
|
0.2 Breaths per minute
Standard Deviation 2.79
|
0.6 Breaths per minute
Standard Deviation 2.91
|
0.6 Breaths per minute
Standard Deviation 2.82
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 2
Respiratory rate, 4 hour
|
-0.1 Breaths per minute
Standard Deviation 3.34
|
-0.1 Breaths per minute
Standard Deviation 2.87
|
-0.1 Breaths per minute
Standard Deviation 3.21
|
-1.0 Breaths per minute
Standard Deviation 2.50
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 2
Respiratory rate, 12 hour
|
0.2 Breaths per minute
Standard Deviation 2.46
|
0.8 Breaths per minute
Standard Deviation 2.93
|
0.8 Breaths per minute
Standard Deviation 2.61
|
-0.5 Breaths per minute
Standard Deviation 2.87
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 2
Respiratory rate, 48 hour
|
-0.2 Breaths per minute
Standard Deviation 2.14
|
-0.5 Breaths per minute
Standard Deviation 2.60
|
0.7 Breaths per minute
Standard Deviation 2.62
|
-0.6 Breaths per minute
Standard Deviation 2.24
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP, DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
DBP, 0.5 hour
|
-0.36 Milliliters of Mercury
Standard Deviation 5.821
|
-3.47 Milliliters of Mercury
Standard Deviation 6.724
|
-3.02 Milliliters of Mercury
Standard Deviation 7.779
|
-1.45 Milliliters of Mercury
Standard Deviation 6.943
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
DBP, 1 hour
|
-4.73 Milliliters of Mercury
Standard Deviation 6.418
|
-6.69 Milliliters of Mercury
Standard Deviation 6.509
|
-5.86 Milliliters of Mercury
Standard Deviation 7.055
|
-5.36 Milliliters of Mercury
Standard Deviation 7.768
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
DBP, 8 hour
|
-7.76 Milliliters of Mercury
Standard Deviation 8.100
|
-8.41 Milliliters of Mercury
Standard Deviation 7.088
|
-6.45 Milliliters of Mercury
Standard Deviation 8.865
|
-8.20 Milliliters of Mercury
Standard Deviation 8.845
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
DBP, 12 hour
|
-6.18 Milliliters of Mercury
Standard Deviation 8.080
|
-7.25 Milliliters of Mercury
Standard Deviation 7.097
|
-7.67 Milliliters of Mercury
Standard Deviation 8.274
|
-7.36 Milliliters of Mercury
Standard Deviation 9.886
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
DBP, 24 hour
|
-4.27 Milliliters of Mercury
Standard Deviation 6.011
|
-7.25 Milliliters of Mercury
Standard Deviation 7.033
|
-4.77 Milliliters of Mercury
Standard Deviation 7.168
|
-5.89 Milliliters of Mercury
Standard Deviation 6.847
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
DBP, 48 hour
|
-0.79 Milliliters of Mercury
Standard Deviation 7.730
|
-2.41 Milliliters of Mercury
Standard Deviation 9.414
|
-1.89 Milliliters of Mercury
Standard Deviation 6.945
|
-1.77 Milliliters of Mercury
Standard Deviation 7.503
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
DBP, 72 hour
|
1.24 Milliliters of Mercury
Standard Deviation 6.544
|
-1.56 Milliliters of Mercury
Standard Deviation 6.361
|
-1.52 Milliliters of Mercury
Standard Deviation 9.187
|
0.80 Milliliters of Mercury
Standard Deviation 9.118
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
SBP, 1 hour
|
-4.14 Milliliters of Mercury
Standard Deviation 9.772
|
2.88 Milliliters of Mercury
Standard Deviation 7.478
|
2.86 Milliliters of Mercury
Standard Deviation 9.186
|
-1.95 Milliliters of Mercury
Standard Deviation 5.959
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
SBP, 2 hour
|
-2.05 Milliliters of Mercury
Standard Deviation 8.873
|
0.28 Milliliters of Mercury
Standard Deviation 9.549
|
-0.08 Milliliters of Mercury
Standard Deviation 7.294
|
-3.95 Milliliters of Mercury
Standard Deviation 6.990
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
SBP, 48 hour
|
1.68 Milliliters of Mercury
Standard Deviation 9.134
|
2.72 Milliliters of Mercury
Standard Deviation 8.437
|
1.36 Milliliters of Mercury
Standard Deviation 7.927
|
0.80 Milliliters of Mercury
Standard Deviation 7.661
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
SBP, 72 hour
|
3.14 Milliliters of Mercury
Standard Deviation 11.277
|
1.81 Milliliters of Mercury
Standard Deviation 8.538
|
3.86 Milliliters of Mercury
Standard Deviation 11.332
|
3.52 Milliliters of Mercury
Standard Deviation 6.752
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
SBP, 4 hour
|
-4.35 Milliliters of Mercury
Standard Deviation 9.423
|
-1.72 Milliliters of Mercury
Standard Deviation 7.699
|
-4.30 Milliliters of Mercury
Standard Deviation 8.270
|
-4.77 Milliliters of Mercury
Standard Deviation 7.717
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
DBP, 2 hour
|
-6.03 Milliliters of Mercury
Standard Deviation 5.840
|
-8.97 Milliliters of Mercury
Standard Deviation 7.104
|
-6.89 Milliliters of Mercury
Standard Deviation 6.173
|
-6.05 Milliliters of Mercury
Standard Deviation 7.745
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
DBP, 4 hour
|
-6.24 Milliliters of Mercury
Standard Deviation 6.148
|
-8.75 Milliliters of Mercury
Standard Deviation 5.879
|
-10.30 Milliliters of Mercury
Standard Deviation 6.722
|
-6.27 Milliliters of Mercury
Standard Deviation 7.799
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
SBP, 0.5 hour
|
-0.32 Milliliters of Mercury
Standard Deviation 8.074
|
5.75 Milliliters of Mercury
Standard Deviation 5.236
|
4.55 Milliliters of Mercury
Standard Deviation 8.543
|
0.17 Milliliters of Mercury
Standard Deviation 5.822
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
SBP, 8 hour
|
-5.32 Milliliters of Mercury
Standard Deviation 10.608
|
-5.06 Milliliters of Mercury
Standard Deviation 9.313
|
-5.23 Milliliters of Mercury
Standard Deviation 9.288
|
-5.27 Milliliters of Mercury
Standard Deviation 7.975
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
SBP, 12 hour
|
-0.47 Milliliters of Mercury
Standard Deviation 10.702
|
-0.03 Milliliters of Mercury
Standard Deviation 8.372
|
-1.05 Milliliters of Mercury
Standard Deviation 9.116
|
-1.58 Milliliters of Mercury
Standard Deviation 9.155
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3A
SBP, 24 hour
|
-1.08 Milliliters of Mercury
Standard Deviation 10.400
|
-0.78 Milliliters of Mercury
Standard Deviation 8.974
|
-2.48 Milliliters of Mercury
Standard Deviation 6.478
|
-2.08 Milliliters of Mercury
Standard Deviation 7.106
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population.
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3A
HR, 0.5 hour
|
2.64 Beats per minute
Standard Deviation 3.900
|
8.28 Beats per minute
Standard Deviation 5.785
|
10.66 Beats per minute
Standard Deviation 4.717
|
2.81 Beats per minute
Standard Deviation 4.156
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3A
HR, 2 hour
|
4.61 Beats per minute
Standard Deviation 4.565
|
11.06 Beats per minute
Standard Deviation 5.891
|
11.41 Beats per minute
Standard Deviation 6.439
|
4.16 Beats per minute
Standard Deviation 4.306
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3A
HR, 8 hour
|
10.79 Beats per minute
Standard Deviation 7.847
|
9.06 Beats per minute
Standard Deviation 5.872
|
10.16 Beats per minute
Standard Deviation 7.407
|
8.56 Beats per minute
Standard Deviation 6.624
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3A
HR, 48 hour
|
9.45 Beats per minute
Standard Deviation 7.527
|
8.50 Beats per minute
Standard Deviation 4.465
|
9.47 Beats per minute
Standard Deviation 7.301
|
8.03 Beats per minute
Standard Deviation 5.290
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3A
HR, 72 hour
|
10.91 Beats per minute
Standard Deviation 10.476
|
9.19 Beats per minute
Standard Deviation 6.708
|
9.59 Beats per minute
Standard Deviation 9.088
|
10.03 Beats per minute
Standard Deviation 8.041
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3A
HR, 1 hour
|
5.52 Beats per minute
Standard Deviation 4.154
|
10.28 Beats per minute
Standard Deviation 6.108
|
12.97 Beats per minute
Standard Deviation 6.573
|
4.66 Beats per minute
Standard Deviation 3.897
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3A
HR, 4 hour
|
5.06 Beats per minute
Standard Deviation 6.910
|
10.16 Beats per minute
Standard Deviation 6.491
|
10.91 Beats per minute
Standard Deviation 5.431
|
4.44 Beats per minute
Standard Deviation 4.629
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3A
HR, 12 hour
|
15.91 Beats per minute
Standard Deviation 9.669
|
15.28 Beats per minute
Standard Deviation 10.232
|
14.38 Beats per minute
Standard Deviation 10.204
|
16.38 Beats per minute
Standard Deviation 8.917
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3A
HR, 24 hour
|
8.73 Beats per minute
Standard Deviation 7.048
|
8.72 Beats per minute
Standard Deviation 5.341
|
7.00 Beats per minute
Standard Deviation 6.673
|
7.28 Beats per minute
Standard Deviation 4.704
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital- Temperature, Part 3A
Temperature, 0.5 hour
|
0.01 Degree Celsius
Standard Deviation 0.344
|
0.21 Degree Celsius
Standard Deviation 0.288
|
0.15 Degree Celsius
Standard Deviation 0.306
|
0.12 Degree Celsius
Standard Deviation 0.303
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3A
Temperature, 8 hour
|
0.12 Degree Celsius
Standard Deviation 0.425
|
0.21 Degree Celsius
Standard Deviation 0.450
|
0.15 Degree Celsius
Standard Deviation 0.409
|
0.15 Degree Celsius
Standard Deviation 0.504
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3A
Temperature, 1 hour
|
0.07 Degree Celsius
Standard Deviation 0.315
|
0.18 Degree Celsius
Standard Deviation 0.252
|
0.12 Degree Celsius
Standard Deviation 0.262
|
0.04 Degree Celsius
Standard Deviation 0.282
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3A
Temperature, 2 hour
|
0.05 Degree Celsius
Standard Deviation 0.268
|
0.26 Degree Celsius
Standard Deviation 0.278
|
0.10 Degree Celsius
Standard Deviation 0.244
|
0.07 Degree Celsius
Standard Deviation 0.317
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3A
Temperature, 4 hour
|
0.15 Degree Celsius
Standard Deviation 0.299
|
0.18 Degree Celsius
Standard Deviation 0.352
|
0.16 Degree Celsius
Standard Deviation 0.305
|
-0.01 Degree Celsius
Standard Deviation 0.402
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3A
Temperature, 12 hour
|
0.27 Degree Celsius
Standard Deviation 0.392
|
0.22 Degree Celsius
Standard Deviation 0.409
|
0.09 Degree Celsius
Standard Deviation 0.366
|
0.27 Degree Celsius
Standard Deviation 0.492
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3A
Temperature, 24 hour
|
0.25 Degree Celsius
Standard Deviation 0.351
|
0.29 Degree Celsius
Standard Deviation 0.429
|
0.06 Degree Celsius
Standard Deviation 0.332
|
0.16 Degree Celsius
Standard Deviation 0.362
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3A
Temperature, 48 hour
|
0.28 Degree Celsius
Standard Deviation 0.473
|
0.34 Degree Celsius
Standard Deviation 0.713
|
0.12 Degree Celsius
Standard Deviation 0.358
|
0.32 Degree Celsius
Standard Deviation 0.327
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3A
Temperature, 72 hour
|
0.20 Degree Celsius
Standard Deviation 0.334
|
0.18 Degree Celsius
Standard Deviation 0.414
|
0.10 Degree Celsius
Standard Deviation 0.418
|
0.18 Degree Celsius
Standard Deviation 0.520
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population.
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3A
Respiratory rate, 2 hour
|
0.7 Breaths per minute
Standard Deviation 2.59
|
0.7 Breaths per minute
Standard Deviation 2.72
|
0.6 Breaths per minute
Standard Deviation 2.30
|
0.2 Breaths per minute
Standard Deviation 2.89
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3A
Respiratory rate, 4 hour
|
0.2 Breaths per minute
Standard Deviation 2.21
|
0.6 Breaths per minute
Standard Deviation 2.76
|
1.1 Breaths per minute
Standard Deviation 2.59
|
0.1 Breaths per minute
Standard Deviation 2.31
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3A
Respiratory rate, 12 hour
|
0.5 Breaths per minute
Standard Deviation 2.33
|
0.9 Breaths per minute
Standard Deviation 3.21
|
0.6 Breaths per minute
Standard Deviation 2.97
|
0.4 Breaths per minute
Standard Deviation 3.11
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3A
Respiratory rate, 0.5 hour
|
0.8 Breaths per minute
Standard Deviation 1.95
|
0.4 Breaths per minute
Standard Deviation 2.51
|
1.5 Breaths per minute
Standard Deviation 2.66
|
-0.2 Breaths per minute
Standard Deviation 2.46
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3A
Respiratory rate, 1 hour
|
0.2 Breaths per minute
Standard Deviation 2.57
|
0.9 Breaths per minute
Standard Deviation 2.83
|
0.8 Breaths per minute
Standard Deviation 2.26
|
-0.7 Breaths per minute
Standard Deviation 2.13
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3A
Respiratory rate, 8 hour
|
0.1 Breaths per minute
Standard Deviation 2.15
|
0.1 Breaths per minute
Standard Deviation 2.85
|
0.5 Breaths per minute
Standard Deviation 2.49
|
-0.3 Breaths per minute
Standard Deviation 2.04
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3A
Respiratory rate, 24 hour
|
0.1 Breaths per minute
Standard Deviation 2.26
|
-0.5 Breaths per minute
Standard Deviation 3.14
|
0.2 Breaths per minute
Standard Deviation 2.75
|
-1.3 Breaths per minute
Standard Deviation 2.58
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3A
Respiratory rate, 48 hour
|
-0.1 Breaths per minute
Standard Deviation 2.45
|
0.0 Breaths per minute
Standard Deviation 2.03
|
0.6 Breaths per minute
Standard Deviation 2.93
|
-0.7 Breaths per minute
Standard Deviation 2.07
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3A
Respiratory rate, 72 hour
|
0.3 Breaths per minute
Standard Deviation 3.05
|
0.6 Breaths per minute
Standard Deviation 2.79
|
0.8 Breaths per minute
Standard Deviation 1.96
|
0.1 Breaths per minute
Standard Deviation 2.59
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population.
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=30 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
DBP, 0.5 hour
|
-2.15 Milliliters of Mercury
Standard Deviation 6.582
|
-1.42 Milliliters of Mercury
Standard Deviation 6.365
|
-2.53 Milliliters of Mercury
Standard Deviation 5.507
|
-1.53 Milliliters of Mercury
Standard Deviation 6.965
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
DBP, 2 hour
|
-5.92 Milliliters of Mercury
Standard Deviation 6.044
|
-6.52 Milliliters of Mercury
Standard Deviation 10.758
|
-5.00 Milliliters of Mercury
Standard Deviation 5.651
|
-5.70 Milliliters of Mercury
Standard Deviation 5.842
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
SBP, 2 hour
|
-4.34 Milliliters of Mercury
Standard Deviation 10.254
|
-0.57 Milliliters of Mercury
Standard Deviation 9.657
|
-1.98 Milliliters of Mercury
Standard Deviation 7.925
|
-1.10 Milliliters of Mercury
Standard Deviation 4.845
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
SBP, 12 hour
|
0.11 Milliliters of Mercury
Standard Deviation 13.298
|
2.17 Milliliters of Mercury
Standard Deviation 11.075
|
0.45 Milliliters of Mercury
Standard Deviation 7.846
|
-1.03 Milliliters of Mercury
Standard Deviation 10.562
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
SBP, 24 hour
|
-2.56 Milliliters of Mercury
Standard Deviation 8.996
|
-0.13 Milliliters of Mercury
Standard Deviation 8.805
|
0.36 Milliliters of Mercury
Standard Deviation 5.210
|
-1.77 Milliliters of Mercury
Standard Deviation 8.458
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
SBP, 72 hour
|
1.76 Milliliters of Mercury
Standard Deviation 8.922
|
2.80 Milliliters of Mercury
Standard Deviation 9.174
|
2.76 Milliliters of Mercury
Standard Deviation 7.236
|
1.70 Milliliters of Mercury
Standard Deviation 9.502
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
SBP, 1 hour
|
0.11 Milliliters of Mercury
Standard Deviation 8.945
|
-1.27 Milliliters of Mercury
Standard Deviation 8.463
|
-0.20 Milliliters of Mercury
Standard Deviation 7.893
|
0.17 Milliliters of Mercury
Standard Deviation 6.823
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
DBP, 1 hour
|
-3.31 Milliliters of Mercury
Standard Deviation 5.569
|
-3.92 Milliliters of Mercury
Standard Deviation 6.443
|
-3.41 Milliliters of Mercury
Standard Deviation 7.157
|
-3.73 Milliliters of Mercury
Standard Deviation 6.027
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
DBP, 4 hour
|
-6.85 Milliliters of Mercury
Standard Deviation 5.455
|
-5.02 Milliliters of Mercury
Standard Deviation 4.481
|
-6.56 Milliliters of Mercury
Standard Deviation 6.488
|
-6.80 Milliliters of Mercury
Standard Deviation 6.884
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
DBP, 8 hour
|
-6.56 Milliliters of Mercury
Standard Deviation 5.815
|
-4.38 Milliliters of Mercury
Standard Deviation 8.616
|
-7.81 Milliliters of Mercury
Standard Deviation 6.258
|
-7.23 Milliliters of Mercury
Standard Deviation 9.095
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
DBP, 12 hour
|
-5.15 Milliliters of Mercury
Standard Deviation 6.431
|
-3.38 Milliliters of Mercury
Standard Deviation 8.189
|
-5.88 Milliliters of Mercury
Standard Deviation 6.644
|
-7.57 Milliliters of Mercury
Standard Deviation 6.494
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
DBP, 24 hour
|
-4.05 Milliliters of Mercury
Standard Deviation 6.571
|
-1.62 Milliliters of Mercury
Standard Deviation 6.464
|
-3.31 Milliliters of Mercury
Standard Deviation 5.118
|
-4.90 Milliliters of Mercury
Standard Deviation 5.636
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
DBP, 48 hour
|
-0.40 Milliliters of Mercury
Standard Deviation 6.512
|
-0.65 Milliliters of Mercury
Standard Deviation 7.945
|
-0.41 Milliliters of Mercury
Standard Deviation 5.491
|
-1.50 Milliliters of Mercury
Standard Deviation 7.405
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
DBP, 72 hour
|
0.31 Milliliters of Mercury
Standard Deviation 4.790
|
0.85 Milliliters of Mercury
Standard Deviation 7.594
|
-0.47 Milliliters of Mercury
Standard Deviation 6.074
|
-0.93 Milliliters of Mercury
Standard Deviation 6.781
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
SBP, 0.5 hour
|
-0.92 Milliliters of Mercury
Standard Deviation 8.734
|
0.77 Milliliters of Mercury
Standard Deviation 9.323
|
0.30 Milliliters of Mercury
Standard Deviation 8.287
|
0.43 Milliliters of Mercury
Standard Deviation 5.157
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
SBP, 4 hour
|
-3.92 Milliliters of Mercury
Standard Deviation 7.959
|
-4.17 Milliliters of Mercury
Standard Deviation 8.680
|
-3.14 Milliliters of Mercury
Standard Deviation 5.501
|
-5.60 Milliliters of Mercury
Standard Deviation 7.831
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
SBP, 8 hour
|
-2.95 Milliliters of Mercury
Standard Deviation 11.644
|
-2.87 Milliliters of Mercury
Standard Deviation 10.059
|
-3.05 Milliliters of Mercury
Standard Deviation 8.804
|
-5.03 Milliliters of Mercury
Standard Deviation 7.294
|
—
|
|
Change From Baseline in Vital- SBP and DBP, Part 3B
SBP, 48 hour
|
0.50 Milliliters of Mercury
Standard Deviation 8.748
|
5.33 Milliliters of Mercury
Standard Deviation 8.963
|
3.45 Milliliters of Mercury
Standard Deviation 6.139
|
1.87 Milliliters of Mercury
Standard Deviation 8.345
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population.
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for HR. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=30 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3B
HR, 0.5 hour
|
3.50 Beats per minute
Standard Deviation 4.911
|
3.05 Beats per minute
Standard Deviation 5.103
|
2.61 Beats per minute
Standard Deviation 4.652
|
2.78 Beats per minute
Standard Deviation 4.928
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3B
HR, 1 hour
|
4.92 Beats per minute
Standard Deviation 5.496
|
6.05 Beats per minute
Standard Deviation 5.784
|
5.70 Beats per minute
Standard Deviation 4.621
|
5.48 Beats per minute
Standard Deviation 7.515
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3B
HR, 4 hour
|
3.69 Beats per minute
Standard Deviation 7.253
|
4.85 Beats per minute
Standard Deviation 6.498
|
4.95 Beats per minute
Standard Deviation 5.564
|
6.22 Beats per minute
Standard Deviation 4.836
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3B
HR, 8 hour
|
7.34 Beats per minute
Standard Deviation 6.462
|
9.65 Beats per minute
Standard Deviation 8.102
|
7.23 Beats per minute
Standard Deviation 6.453
|
8.78 Beats per minute
Standard Deviation 8.137
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3B
HR, 24 hour
|
6.92 Beats per minute
Standard Deviation 6.162
|
8.02 Beats per minute
Standard Deviation 6.086
|
7.77 Beats per minute
Standard Deviation 6.677
|
7.72 Beats per minute
Standard Deviation 5.700
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3B
HR, 48 hour
|
8.18 Beats per minute
Standard Deviation 6.657
|
9.72 Beats per minute
Standard Deviation 5.845
|
8.08 Beats per minute
Standard Deviation 6.610
|
10.15 Beats per minute
Standard Deviation 9.207
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3B
HR, 2 hour
|
3.76 Beats per minute
Standard Deviation 5.524
|
6.08 Beats per minute
Standard Deviation 5.706
|
5.67 Beats per minute
Standard Deviation 4.148
|
5.58 Beats per minute
Standard Deviation 7.157
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3B
HR, 12 hour
|
15.50 Beats per minute
Standard Deviation 6.925
|
15.85 Beats per minute
Standard Deviation 9.232
|
13.89 Beats per minute
Standard Deviation 7.574
|
16.62 Beats per minute
Standard Deviation 7.800
|
—
|
|
Change From Baseline in Vital Signs-Heart Rate, Part 3B
HR, 72 hour
|
9.18 Beats per minute
Standard Deviation 7.853
|
10.78 Beats per minute
Standard Deviation 8.397
|
7.37 Beats per minute
Standard Deviation 7.256
|
9.62 Beats per minute
Standard Deviation 7.245
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=30 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital- Temperature, Part 3B
Temperature, 1 hour (n=30,31,32,30)
|
0.07 Degree Celsius
Standard Deviation 0.290
|
0.06 Degree Celsius
Standard Deviation 0.275
|
0.10 Degree Celsius
Standard Deviation 0.330
|
0.09 Degree Celsius
Standard Deviation 0.291
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3B
Temperature, 12 hour (n=30,31,32,30)
|
0.39 Degree Celsius
Standard Deviation 0.358
|
0.31 Degree Celsius
Standard Deviation 0.470
|
0.32 Degree Celsius
Standard Deviation 0.463
|
0.45 Degree Celsius
Standard Deviation 0.425
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3B
Temperature, 0.5 hour (n=30,31,32,30)
|
0.13 Degree Celsius
Standard Deviation 0.329
|
0.06 Degree Celsius
Standard Deviation 0.239
|
0.11 Degree Celsius
Standard Deviation 0.404
|
0.05 Degree Celsius
Standard Deviation 0.256
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3B
Temperature, 2 hour (n=29,31,32,30)
|
0.07 Degree Celsius
Standard Deviation 0.330
|
0.05 Degree Celsius
Standard Deviation 0.341
|
0.09 Degree Celsius
Standard Deviation 0.316
|
0.04 Degree Celsius
Standard Deviation 0.233
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3B
Temperature, 4 hour(n=30,31,32,30)
|
0.05 Degree Celsius
Standard Deviation 0.385
|
0.10 Degree Celsius
Standard Deviation 0.371
|
0.07 Degree Celsius
Standard Deviation 0.430
|
0.09 Degree Celsius
Standard Deviation 0.275
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3B
Temperature, 8 hour (n=30,31,32,30)
|
0.22 Degree Celsius
Standard Deviation 0.419
|
0.29 Degree Celsius
Standard Deviation 0.497
|
0.23 Degree Celsius
Standard Deviation 0.456
|
0.17 Degree Celsius
Standard Deviation 0.502
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3B
Temperature, 24 hour (n=30,31,32,30)
|
0.12 Degree Celsius
Standard Deviation 0.453
|
0.34 Degree Celsius
Standard Deviation 0.347
|
0.23 Degree Celsius
Standard Deviation 0.352
|
0.19 Degree Celsius
Standard Deviation 0.420
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3B
Temperature, 48 hour (n=30,31,32,30)
|
0.13 Degree Celsius
Standard Deviation 0.424
|
0.19 Degree Celsius
Standard Deviation 0.448
|
0.16 Degree Celsius
Standard Deviation 0.456
|
0.22 Degree Celsius
Standard Deviation 0.444
|
—
|
|
Change From Baseline in Vital- Temperature, Part 3B
Temperature, 72 hour (n=30,31,31,30)
|
0.26 Degree Celsius
Standard Deviation 0.446
|
0.33 Degree Celsius
Standard Deviation 0.422
|
0.14 Degree Celsius
Standard Deviation 0.450
|
0.08 Degree Celsius
Standard Deviation 0.377
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 3Population: Safety Population.
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=30 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B
Respiratory rate, 4 hour (n=30,31,32,30)
|
0.1 Breaths per minute
Standard Deviation 3.47
|
0.3 Breaths per minute
Standard Deviation 2.68
|
-0.4 Breaths per minute
Standard Deviation 2.85
|
0.5 Breaths per minute
Standard Deviation 2.76
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B
Respiratory rate, 8 hour(n=30,31,32,30)
|
0.9 Breaths per minute
Standard Deviation 3.31
|
0.4 Breaths per minute
Standard Deviation 2.50
|
0.0 Breaths per minute
Standard Deviation 3.41
|
0.5 Breaths per minute
Standard Deviation 2.75
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B
Respiratory rate, 12 hour (n=30,31,32,30)
|
-0.3 Breaths per minute
Standard Deviation 2.82
|
-0.8 Breaths per minute
Standard Deviation 2.67
|
0.2 Breaths per minute
Standard Deviation 2.96
|
1.1 Breaths per minute
Standard Deviation 2.89
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B
Respiratory rate, 24 hour(n=30,31,32,30)
|
-0.7 Breaths per minute
Standard Deviation 3.08
|
-1.3 Breaths per minute
Standard Deviation 3.29
|
-0.6 Breaths per minute
Standard Deviation 2.50
|
0.1 Breaths per minute
Standard Deviation 3.04
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B
Respiratory rate, 48 hour(n=30,31,32,30)
|
-0.0 Breaths per minute
Standard Deviation 3.35
|
-0.8 Breaths per minute
Standard Deviation 2.81
|
-0.1 Breaths per minute
Standard Deviation 3.15
|
1.2 Breaths per minute
Standard Deviation 3.09
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B
Respiratory rate, 0.5 hour (n=30,31,32,30)
|
0.4 Breaths per minute
Standard Deviation 2.99
|
-0.3 Breaths per minute
Standard Deviation 2.78
|
-0.8 Breaths per minute
Standard Deviation 3.08
|
0.8 Breaths per minute
Standard Deviation 3.06
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B
Respiratory rate, 1 hour (n=30,31,32,30)
|
-0.7 Breaths per minute
Standard Deviation 3.08
|
-0.6 Breaths per minute
Standard Deviation 2.88
|
-0.1 Breaths per minute
Standard Deviation 2.98
|
0.2 Breaths per minute
Standard Deviation 2.06
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B
Respiratory rate, 2 hour (n=30,31,32,30)
|
0.6 Breaths per minute
Standard Deviation 3.64
|
-0.2 Breaths per minute
Standard Deviation 2.93
|
-0.1 Breaths per minute
Standard Deviation 3.20
|
0.6 Breaths per minute
Standard Deviation 2.31
|
—
|
|
Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B
Respiratory rate, 72 hour (n=30,31,31,30)
|
-0.0 Breaths per minute
Standard Deviation 2.95
|
-0.1 Breaths per minute
Standard Deviation 3.73
|
0.2 Breaths per minute
Standard Deviation 2.89
|
0.6 Breaths per minute
Standard Deviation 2.85
|
—
|
SECONDARY outcome
Timeframe: Up to Day 3Population: Safety Population
12-lead ECG, was measured in semi-supine position after 5 minutes rest. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=23 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=23 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=22 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings, -Part 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 3Population: Safety Population
12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal ECG Findings, -Part 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 3Population: Safety Population
12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal ECG Findings, -Part 3A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 3Population: Safety Population
12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=30 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal ECG Findings, -Part 3B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 3Population: Safety Population.
Blood samples were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=23 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=23 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=22 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Lymphocyte, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Neutrophils, low
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Neutrophils, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Platelets, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Leukocytes, low
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Leukocytes, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Hematocrit, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Hematocrit, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Hemoglobin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Hemoglobin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Lymphocytes, low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Platelets, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Hematology Values of PCI - Part 2
Hematocrit, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 2
Hematocrit, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 2
Hemoglobin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 2
Lymphocytes, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 2
Neutrophils, low
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 2
Neutrophils, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 2
Platelets, low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 2
Leukocytes, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 2
Leukocytes, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 2
Lymphocytes, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 2
Hemoglobin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 2
Platelets, high
|
0 Participants
|
0 Participants
|
0 Participants
|
00 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. It was conducted at Day 2 (48 hours). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Hematology Values of PCI - Part 3A
Hematocrit, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3A
Hemoglobin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3A
Hemoglobin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3A
Lymphocytes, low
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3A
Neutrophils, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3A
Platelets, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3A
Platelets, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3A
Leukocytes, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3A
Leukocytes, low
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3A
Hematocrit, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3A
Lymphocytes, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3A
Neutrophils, low
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. It was conducted at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=30 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Hematology Values of PCI - Part 3B
Lymphocytes, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3B
Neutrophils, low
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3B
Neutrophils, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3B
Platelets, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3B
Platelets, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3B
Leukocytes, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3B
Leukocytes, low
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3B
Hematocrit, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3B
Hematocrit, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3B
Hemoglobin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3B
Hemoglobin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Hematology Values of PCI - Part 3B
Lymphocytes, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population
Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=23 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=23 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=22 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Values of PCI- Part1
Glucose, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part1
Albumin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part1
Albumin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part1
Calcium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part1
Calcium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part1
Potassium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part1
Potassium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part1
Sodium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part1
Sodium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part1
Glucose, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 2
Glucose, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 2
Glucose, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 2
Albumin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 2
Calcium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 2
Calcium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 2
Potassium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 2
Potassium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 2
Sodium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 2
Sodium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 2
Albumin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3A
Glucose, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3A
Glucose, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3A
Albumin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3A
Albumin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3A
Calcium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3A
Calcium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3A
Potassium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3A
Potassium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3A
Sodium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3A
Sodium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population
Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=30 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3B
Sodium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3B
Glucose, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3B
Glucose, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3B
Albumin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3B
Albumin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3B
Calcium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3B
Calcium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3B
Potassium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3B
Potassium, high
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Chemistry Values of PCI- Part 3B
Sodium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 2Population: Safety Population.
Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=23 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=23 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=22 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Protein, trace-lysed, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Ketone, trace-lysed, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Ketone, trace-intact, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Ketone, trace, Day -1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Ketone, 2+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Ketone 1+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Ketone, trace-lysed, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Ketone, trace-intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Ketone, trace, 48 hour
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Ketone, 2+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Ketone 1+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Glucose, trace-lysed, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Glucose, trace, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Glucose, 2+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Glucose, 1+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Glucose, trace-lysed, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Glucose, trace-Intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Glucose, trace, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Glucose, 2+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Glucose, 1+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Occult blood, trace-lysed, Day -1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Occult blood, trace-Intact, Day -1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Occult blood, trace, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Occult blood, 2+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Occult blood, 1+, Day -1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Occult blood, trace-lysed, 48 hour
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Occult blood, trace-Intact, 48 hour
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Occult blood, trace, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Occult blood, 2+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Occult blood, 1+, 48 hour
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Protein, trace-lysed, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Protein, trace-Intact, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Protein, trace, Day -1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Protein, 2+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Protein, 1+, Day -1
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Protein, trace-Intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Protein, trace, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Protein, 2+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Protein, 1+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Glucose, trace-Intact, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 2Population: Safety Population
Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Ketone, trace-intact, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Ketone, trace, Day -1
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Ketone, 2+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Ketone, trace-intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Ketone, trace, 48 hour
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Ketone, 2+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Glucose, trace-Intact, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Glucose, trace, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Glucose, 2+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Glucose, trace-Intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Glucose, trace, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Glucose, 2+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Occult blood, trace-Intact, Day -1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Occult blood, trace, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Occult blood, 2+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Occult blood, trace-Intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Occult blood, trace, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Occult blood, 2+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Protein, trace-Intact, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Protein, trace-Intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Protein, trace, 48 hour
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Protein, 2+, 48 hour
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Protein, trace, Day -1
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Protein, 2+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 2Population: Safety Population
Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Glucose, trace, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Glucose, 2+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Ketone, trace-lysed, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Ketone, trace-intact, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Ketone, trace, Day -1
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Ketone, 2+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Ketone 1+, Day -1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Ketone, trace-lysed, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Ketone, trace-intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Ketone, trace, 48 hour
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Ketone, 2+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Ketone 1+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Glucose, trace-lysed, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Glucose, trace-Intact, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Glucose, 1+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Glucose, trace-lysed, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Glucose, trace-Intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Glucose, trace, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Glucose, 2+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Glucose, 1+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Occult blood, trace-lysed, Day -1
|
6 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Occult blood, trace-Intact, Day -1
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Occult blood, trace, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Occult blood, 2+, Day -1
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Occult blood, 1+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Occult blood, trace-lysed, 48 hour
|
5 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Occult blood, trace-Intact, 48 hour
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Occult blood, trace, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Occult blood, 1+, 48 hour
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Protein, trace-lysed, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Protein, trace-Intact, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Protein, trace, Day -1
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Protein, 2+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Protein, 1+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Protein, trace-lysed, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Protein, trace-Intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Protein, trace, 48 hour
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Protein, 2+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Protein, 1+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Occult blood, 2+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 2Population: Safety Population.
Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=30 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Ketone, trace-lysed, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Ketone, trace-intact, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Ketone, trace, Day -1
|
4 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Ketone, 3+, Day -1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Ketone, trace-lysed, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Ketone, trace-intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Ketone, trace, 48 hour
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Ketone, 3+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Glucose, trace-lysed, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Glucose, trace-Intact, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Glucose, trace, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Glucose, 3+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Glucose, trace-lysed, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Glucose, trace-Intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Glucose, trace, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Glucose, 3+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Occult blood, trace-lysed, Day -1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Occult blood, trace-Intact, Day -1
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Occult blood, trace, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Occult blood, trace-Intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Occult blood, trace, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Occult blood, 3+, 48 hour
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Protein, trace-lysed, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Protein, 3+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Occult blood, 3+, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Occult blood, trace-lysed, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Protein, trace-Intact, Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Protein, trace, Day -1
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Protein, trace-lysed, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Protein, trace-Intact, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Protein, trace, 48 hour
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Protein, 3+, 48 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 42 daysPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=23 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=23 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=22 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
n=21 Participants
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1
Any AE
|
13 Participants
|
12 Participants
|
13 Participants
|
15 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to 35 daysPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=20 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=21 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=20 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=20 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With SAEs and AEs-Part 2
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With SAEs and AEs-Part 2
Any AE
|
12 Participants
|
13 Participants
|
14 Participants
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 44 daysPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=33 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=32 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With SAEs and AEs-Part 3A
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With SAEs and AEs-Part 3A
Any AE
|
21 Participants
|
24 Participants
|
25 Participants
|
23 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 44 daysPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis.
Outcome measures
| Measure |
Part 3B,Treatment R4
n=31 Participants
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y2
n=30 Participants
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3A,Treatment R1
n=32 Participants
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=30 Participants
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 1, Treatment R
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
|---|---|---|---|---|---|
|
Number of Participants With SAEs and AEs-Part 3B
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With SAEs and AEs-Part 3B
Any AE
|
18 Participants
|
20 Participants
|
24 Participants
|
15 Participants
|
—
|
Adverse Events
Part 1,Treatment F1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 1,Treatment F2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part 1,Treatment F3
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Part 1,Treatment F4
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Part 1, Treatment R
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part 2, Treatment R
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Part 2, Treatment FG1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part 2, Treatment FG2
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Part 2, Treatment FG3
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part 3A,Treatment X1
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Part 3A,Treatment X2
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Part 3A,Treatment R1
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Part 3A,Treatment R2
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Part 3B,Treatment Y1
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Part 3B,Treatment Y2
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Part 3B,Treatment R3
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Part 3B,Treatment R4
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1,Treatment F1
n=21 participants at risk
In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2.
|
Part 1,Treatment F2
n=23 participants at risk
In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3.
|
Part 1,Treatment F3
n=23 participants at risk
In the F3 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): GSK3380154, TABA, Tablet Weight 560mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently, which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F4.
|
Part 1,Treatment F4
n=22 participants at risk
In the F4 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently, which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose R.
|
Part 1, Treatment R
n=21 participants at risk
In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
Part 2, Treatment R
n=21 participants at risk
Participants were administered 2 monotherapies ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
|
Part 2, Treatment FG1
n=20 participants at risk
Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2.
|
Part 2, Treatment FG2
n=20 participants at risk
Participants were administered the FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG2 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG3.
|
Part 2, Treatment FG3
n=20 participants at risk
Participants were administered the FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG3 was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose R.
|
Part 3A,Treatment X1
n=32 participants at risk
In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, particpants recived a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2.
|
Part 3A,Treatment X2
n=33 participants at risk
In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1.
|
Part 3A,Treatment R1
n=32 participants at risk
In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
|
Part 3A,Treatment R2
n=32 participants at risk
In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
|
Part 3B,Treatment Y1
n=30 participants at risk
In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2
|
Part 3B,Treatment Y2
n=31 participants at risk
In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
|
Part 3B,Treatment R3
n=32 participants at risk
In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4.
|
Part 3B,Treatment R4
n=30 participants at risk
In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Nervous system disorders
Headache
|
28.6%
6/21 • Number of events 6 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
47.8%
11/23 • Number of events 11 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
43.5%
10/23 • Number of events 10 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
59.1%
13/22 • Number of events 15 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
47.6%
10/21 • Number of events 12 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
61.9%
13/21 • Number of events 14 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
45.0%
9/20 • Number of events 10 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
65.0%
13/20 • Number of events 15 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
55.0%
11/20 • Number of events 11 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
53.1%
17/32 • Number of events 18 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
60.6%
20/33 • Number of events 21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
68.8%
22/32 • Number of events 24 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
68.8%
22/32 • Number of events 23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
60.0%
18/30 • Number of events 18 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
41.9%
13/31 • Number of events 13 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
50.0%
16/32 • Number of events 16 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
33.3%
10/30 • Number of events 10 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
8.7%
2/23 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.3%
1/23 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.5%
1/22 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.8%
1/21 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
19.0%
4/21 • Number of events 4 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
13.0%
3/23 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
8.7%
2/23 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
9.1%
2/22 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.8%
1/21 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
14.3%
3/21 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
15.0%
3/20 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
15.0%
3/20 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
10.0%
2/20 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.2%
2/32 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
9.1%
3/33 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
9.4%
3/32 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.1%
1/32 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.3%
1/30 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.2%
1/31 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.2%
2/32 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.7%
2/30 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.3%
1/23 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.3%
1/23 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.5%
1/22 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
9.5%
2/21 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.3%
1/23 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
9.1%
2/22 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.8%
1/21 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
10.0%
2/20 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.1%
1/32 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
15.2%
5/33 • Number of events 5 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
9.4%
3/32 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.1%
1/32 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
13.3%
4/30 • Number of events 4 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.2%
1/31 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
12.5%
4/32 • Number of events 4 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.3%
1/30 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.5%
2/21 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.5%
1/22 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.8%
1/21 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
14.3%
3/21 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
15.0%
3/20 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.2%
1/31 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.2%
2/32 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Eye disorders
Eye swelling
|
4.8%
1/21 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
8.7%
2/23 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.5%
1/22 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Eye disorders
Photophobia
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.3%
1/23 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
13.0%
3/23 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
8.7%
2/23 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.3%
1/23 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.8%
1/21 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
15.0%
3/20 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
9.4%
3/32 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
9.1%
3/33 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.2%
2/32 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
15.6%
5/32 • Number of events 5 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
10.0%
3/30 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.5%
2/31 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
9.4%
3/32 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Vascular disorders
Flushing
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.1%
1/32 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.1%
1/32 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.2%
2/32 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.5%
2/31 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.7%
2/30 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Vascular disorders
Hot flush
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
General disorders
Fatigue
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.8%
1/21 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
General disorders
Gait disturbance
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Reproductive system and breast disorders
Erection increased
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
4.8%
1/21 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Cardiac disorders
Palpitations
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.2%
2/32 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.1%
1/32 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.1%
1/32 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Eye disorders
Eye pain
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
9.4%
3/32 • Number of events 3 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
5.0%
1/20 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
9.4%
3/32 • Number of events 4 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.1%
2/33 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
15.6%
5/32 • Number of events 5 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.1%
1/32 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.1%
1/32 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.1%
2/33 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.1%
1/32 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.2%
2/32 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.2%
2/32 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.1%
1/32 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.2%
2/32 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.2%
2/32 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/30 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/23 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/22 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/21 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/20 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/33 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/32 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.3%
1/30 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
0.00%
0/31 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
3.1%
1/32 • Number of events 1 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
6.7%
2/30 • Number of events 2 • All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days)
Safety population included all the participants enrolled into the study who received atleast one dose of investigational product, was used to assess AE's and SAE's
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER