Trial Outcomes & Findings for To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706 (NCT NCT01763333)
NCT ID: NCT01763333
Last Updated: 2019-03-25
Results Overview
Percentage of subjects with drug related adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
Results posted on
2019-03-25
Participant Flow
Subjects were recruited from the volunteers' pool of the Human Pharmacology Centre of Boehringer Ingelheim (BI) Pharma GmbH \& Co. KG, Ingelheim, Germany.Only male subjects were included because no data on reproductive toxicology was available.
68 subjects were randomised for single rising dose (SRD) part \&12 subjects for bioavailability(BA) part of study.
Participant milestones
| Measure |
BI 1026706 - Tablet 25 mg (SRD - Part)
Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 50 mg (SRD - Part)
Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 100 mg (SRD - Part)
Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 200 mg (SRD - Part)
Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 400 mg (SRD - Part)
Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 10 mg (SRD - Part)
Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
|
BI 1026706 - Solution 100 mg (SRD - Part)
Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition
|
BI 1026706 - Solution 200 mg (SRD - Part)
Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
|
BI 1026706 - Solution 400 mg (SRD - Part)
Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
|
Placebo (SRD - Part)
Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
|
R1/T1/R2/T2 (BA - Part)
Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100mg film coated tablet (R1) under fasted condition, followed by 100mg film coated tablet (T1) under fed condition, 100 mg drinking solution (R2) under fasting and in the last treatment period with 100 mg drinking solution (T2) under fed condition. There was washout period of 7days between the respective treatments.
|
T1/T2/R1/R2 (BA - Part)
Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning. First they were treated with 100mg film coated tablet (T1) under fed condition, followed by 100 mg drinking solution (T2) under fed condition, 100mg film coated tablet (R1) under fasted condition and in the last treatment period with 100 mg drinking solution (R2) under fasting condition. There was a washout period of 7days between the respective treatments.
|
R2/R1/T2/T1 (BA - Part)
Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100 mg drinking solution (R2) under fasting condition, followed by 100mg film coated tablet (R1) under fasted condition,100 mg drinking solution (T2) under fed condition and in the last treatment period with 100mg film coated tablet (T1) under fed condition. There was washout period of 7days between the respective treatments.
|
T2/R2/T1/R1 (BA - Part)
Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100 mg drinking solution (T2) under fed condition, followed by 100 mg drinking solution (R2) under fasting, 100mg film coated tablet (T1) under fed condition and in the last treatment period with 100mg film coated tablet (R1) under fasted condition. There was washout period of 7days between the respective treatments.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
4
|
6
|
5
|
6
|
5
|
18
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
4
|
6
|
5
|
6
|
5
|
18
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706
Baseline characteristics by cohort
| Measure |
BI 1026706 - Tablet 25 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 50 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 100 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 400 mg (SRD - Part)
n=4 Participants
Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 10 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
|
BI 1026706 - Solution 100 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition
|
BI 1026706 - Solution 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
|
BI 1026706 - Solution 400 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
|
Placebo (SRD - Part)
n=18 Participants
Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
|
R1/T1/R2/T2 (BA - Part)
n=3 Participants
Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100mg film coated tablet (R1) under fasted condition, followed by 100mg film coated tablet (T1) under fed condition, 100 mg drinking solution (R2) under fasting and in the last treatment period with 100 mg drinking solution (T2) under fed condition. There was washout period of 7days between the respective treatments.
|
T1/T2/R1/R2 (BA - Part)
n=3 Participants
Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning. First they were treated with 100mg film coated tablet (T1) under fed condition, followed by 100 mg drinking solution (T2) under fed condition, 100mg film coated tablet (R1) under fasted condition and in the last treatment period with 100 mg drinking solution (R2) under fasting condition. There was a washout period of 7days between the respective treatments.
|
R2/R1/T2/T1 (BA - Part)
n=3 Participants
Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100 mg drinking solution (R2) under fasting condition, followed by 100mg film coated tablet (R1) under fasted condition,100 mg drinking solution (T2) under fed condition and in the last treatment period with 100mg film coated tablet (T1) under fed condition. There was washout period of 7days between the respective treatments.
|
T2/R2/T1/R1 (BA - Part)
n=3 Participants
Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100 mg drinking solution (T2) under fed condition, followed by 100 mg drinking solution (R2) under fasting, 100mg film coated tablet (T1) under fed condition and in the last treatment period with 100mg film coated tablet (R1) under fasted condition. There was washout period of 7days between the respective treatments.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.8 Years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
39.0 Years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
35.5 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
39.5 Years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
42.0 Years
STANDARD_DEVIATION 5.7 • n=21 Participants
|
39.7 Years
STANDARD_DEVIATION 8.0 • n=8 Participants
|
43.4 Years
STANDARD_DEVIATION 7.8 • n=8 Participants
|
35.7 Years
STANDARD_DEVIATION 9.2 • n=24 Participants
|
32.4 Years
STANDARD_DEVIATION 12.0 • n=42 Participants
|
35.9 Years
STANDARD_DEVIATION 7.2 • n=42 Participants
|
32.7 Years
STANDARD_DEVIATION 12.4 • n=42 Participants
|
27.0 Years
STANDARD_DEVIATION 3.6 • n=42 Participants
|
26.7 Years
STANDARD_DEVIATION 4.9 • n=36 Participants
|
27.0 Years
STANDARD_DEVIATION 5.6 • n=36 Participants
|
36.3 Years
STANDARD_DEVIATION 8.2 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
80 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.Population: The treated set (TS) included all subjects who were documented to have taken at least one dose of study medication.
Percentage of subjects with drug related adverse events.
Outcome measures
| Measure |
BI 1026706 - Tablet 25 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 50 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 100 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 400 mg (SRD - Part)
n=4 Participants
Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 10 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
|
BI 1026706 - Solution 100 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition
|
BI 1026706 - Solution 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
|
BI 1026706 - Solution 400 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
|
Placebo (SRD - Part)
n=18 Participants
Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 100 mg Fasted (R2)
n=11 Participants
Subjects were treated with 100 mg drinking solution (R2) under fasting condition.
|
BI 1026706 - 100 mg Solution Fed (T2)
n=12 Participants
Subjects were treated with 100 mg drinking solution (T2) under fed condition.
|
BI 1026706 - Tablet 100 mg Fasted (R1)
n=12 Participants
Subjects were treated with 100mg film coated tablet (R1) under fasted condition.
|
BI 1026706 - Tablet 100 mg Fed (T1)
n=10 Participants
Subjects were treated with 100mg film coated tablet (T1) under fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Drug Related Adverse Events
|
0.0 Percentage of participants
|
33.3 Percentage of participants
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
0.0 Percentage of participants
|
20.0 Percentage of participants
|
16.7 Percentage of participants
|
60.0 Percentage of participants
|
22.2 Percentage of participants
|
0.0 Percentage of participants
|
8.3 Percentage of participants
|
16.7 Percentage of participants
|
20.0 Percentage of participants
|
SECONDARY outcome
Timeframe: -2.0 hours (h) before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosingPopulation: TS-SRD, TS-BA, PPS-DP, PPS-BA-T1-R1, PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1
Maximum measured concentration of the analyte in plasma (Cmax). The treated set-SRD Part (TS-SRD) included all 68 subjects from the TS who participated in the SRD Part. The treated set-BA Part (TS-BA) included all 12 subjects from the TS who participated in the BA Part. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) included all subjects of the TS-BA who provided observations under the reference treatment (R1) or test treatment (T1) for at least one of the endpoints Cmax, AUC0-tz, or AUC0-inf,without experiencing emesis at or before two times median tmax and without important protocol violations (PVs) relevant to the statistical evaluation of pharmacokinetic (PK). The same definition applies for the analysis set PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1.
Outcome measures
| Measure |
BI 1026706 - Tablet 25 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 50 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 100 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 400 mg (SRD - Part)
n=4 Participants
Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 10 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
|
BI 1026706 - Solution 100 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition
|
BI 1026706 - Solution 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
|
BI 1026706 - Solution 400 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
|
Placebo (SRD - Part)
n=11 Participants
Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 100 mg Fasted (R2)
n=12 Participants
Subjects were treated with 100 mg drinking solution (R2) under fasting condition.
|
BI 1026706 - 100 mg Solution Fed (T2)
n=12 Participants
Subjects were treated with 100 mg drinking solution (T2) under fed condition.
|
BI 1026706 - Tablet 100 mg Fasted (R1)
n=10 Participants
Subjects were treated with 100mg film coated tablet (R1) under fasted condition.
|
BI 1026706 - Tablet 100 mg Fed (T1)
Subjects were treated with 100mg film coated tablet (T1) under fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax
|
117 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 33.1
|
268 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 42.9
|
623 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 40.9
|
728 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 26.8
|
1430 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 80.0
|
112 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 32.9
|
1150 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 47.1
|
2210 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 28.0
|
3090 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 24.8
|
1340 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 32.0
|
706 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 33.5
|
560 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 34.8
|
651 nanomoles Per Litre (nmol/L)
Geometric Coefficient of Variation 34.4
|
—
|
SECONDARY outcome
Timeframe: -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosingPopulation: The treated set-SRD Part (TS-SRD) included all 68 subjects from the TS who participated in the SRD Part. The treated set-BA Part (TS-BA) included all 12 subjects from the TS who participated in the BA Part.
Time from dosing to maximum measured concentration (tmax).
Outcome measures
| Measure |
BI 1026706 - Tablet 25 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 50 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 100 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 400 mg (SRD - Part)
n=4 Participants
Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 10 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
|
BI 1026706 - Solution 100 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition
|
BI 1026706 - Solution 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
|
BI 1026706 - Solution 400 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
|
Placebo (SRD - Part)
n=11 Participants
Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 100 mg Fasted (R2)
n=12 Participants
Subjects were treated with 100 mg drinking solution (R2) under fasting condition.
|
BI 1026706 - 100 mg Solution Fed (T2)
n=12 Participants
Subjects were treated with 100 mg drinking solution (T2) under fed condition.
|
BI 1026706 - Tablet 100 mg Fasted (R1)
n=10 Participants
Subjects were treated with 100mg film coated tablet (R1) under fasted condition.
|
BI 1026706 - Tablet 100 mg Fed (T1)
Subjects were treated with 100mg film coated tablet (T1) under fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax (Time From Dosing to Maximum Measured Concentration)
|
1.74 hours
Interval 0.75 to 4.07
|
1.51 hours
Interval 1.0 to 3.0
|
1.75 hours
Interval 0.73 to 4.02
|
1.25 hours
Interval 0.76 to 4.02
|
2.23 hours
Interval 1.0 to 3.0
|
0.63 hours
Interval 0.5 to 1.0
|
0.50 hours
Interval 0.5 to 0.76
|
0.75 hours
Interval 0.42 to 0.75
|
0.75 hours
Interval 0.42 to 1.0
|
0.52 hours
Interval 0.5 to 0.75
|
0.75 hours
Interval 0.5 to 1.0
|
1.74 hours
Interval 0.75 to 3.02
|
1.26 hours
Interval 0.5 to 2.0
|
—
|
SECONDARY outcome
Timeframe: -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosingPopulation: TS-SRD, TS-BA, PPS-DP, PPS-BA-T1-R1, PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Outcome measures
| Measure |
BI 1026706 - Tablet 25 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 50 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 100 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 400 mg (SRD - Part)
n=4 Participants
Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 10 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
|
BI 1026706 - Solution 100 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition
|
BI 1026706 - Solution 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
|
BI 1026706 - Solution 400 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
|
Placebo (SRD - Part)
n=11 Participants
Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 100 mg Fasted (R2)
n=12 Participants
Subjects were treated with 100 mg drinking solution (R2) under fasting condition.
|
BI 1026706 - 100 mg Solution Fed (T2)
n=12 Participants
Subjects were treated with 100 mg drinking solution (T2) under fed condition.
|
BI 1026706 - Tablet 100 mg Fasted (R1)
n=10 Participants
Subjects were treated with 100mg film coated tablet (R1) under fasted condition.
|
BI 1026706 - Tablet 100 mg Fed (T1)
Subjects were treated with 100mg film coated tablet (T1) under fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-inf
|
768 nmol*h/L
Geometric Coefficient of Variation 28.6
|
1690 nmol*h/L
Geometric Coefficient of Variation 51.8
|
3990 nmol*h/L
Geometric Coefficient of Variation 30.9
|
4040 nmol*h/L
Geometric Coefficient of Variation 29.4
|
8900 nmol*h/L
Geometric Coefficient of Variation 85.1
|
428 nmol*h/L
Geometric Coefficient of Variation 41.9
|
3220 nmol*h/L
Geometric Coefficient of Variation 43.5
|
7790 nmol*h/L
Geometric Coefficient of Variation 26.9
|
11300 nmol*h/L
Geometric Coefficient of Variation 28.3
|
4590 nmol*h/L
Geometric Coefficient of Variation 33.1
|
3380 nmol*h/L
Geometric Coefficient of Variation 28.6
|
3270 nmol*h/L
Geometric Coefficient of Variation 28.3
|
2930 nmol*h/L
Geometric Coefficient of Variation 40.8
|
—
|
SECONDARY outcome
Timeframe: -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosingPopulation: TS-SRD, TS-BA, PPS-DP, PPS-BA-T1-R1, PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0- tz).
Outcome measures
| Measure |
BI 1026706 - Tablet 25 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 50 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 100 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 400 mg (SRD - Part)
n=4 Participants
Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 10 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
|
BI 1026706 - Solution 100 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition
|
BI 1026706 - Solution 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
|
BI 1026706 - Solution 400 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
|
Placebo (SRD - Part)
n=11 Participants
Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 100 mg Fasted (R2)
n=12 Participants
Subjects were treated with 100 mg drinking solution (R2) under fasting condition.
|
BI 1026706 - 100 mg Solution Fed (T2)
n=12 Participants
Subjects were treated with 100 mg drinking solution (T2) under fed condition.
|
BI 1026706 - Tablet 100 mg Fasted (R1)
n=10 Participants
Subjects were treated with 100mg film coated tablet (R1) under fasted condition.
|
BI 1026706 - Tablet 100 mg Fed (T1)
Subjects were treated with 100mg film coated tablet (T1) under fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0- tz
|
741 nmol*h/L
Geometric Coefficient of Variation 25.2
|
1670 nmol*h/L
Geometric Coefficient of Variation 51.8
|
3950 nmol*h/L
Geometric Coefficient of Variation 30.5
|
3990 nmol*h/L
Geometric Coefficient of Variation 28.6
|
8830 nmol*h/L
Geometric Coefficient of Variation 85.3
|
403 nmol*h/L
Geometric Coefficient of Variation 44.0
|
3170 nmol*h/L
Geometric Coefficient of Variation 27.0
|
7710 nmol*h/L
Geometric Coefficient of Variation 27.0
|
11300 nmol*h/L
Geometric Coefficient of Variation 28.3
|
4550 nmol*h/L
Geometric Coefficient of Variation 33.3
|
3360 nmol*h/L
Geometric Coefficient of Variation 28.9
|
3240 nmol*h/L
Geometric Coefficient of Variation 28.3
|
2900 nmol*h/L
Geometric Coefficient of Variation 40.8
|
—
|
SECONDARY outcome
Timeframe: -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosingPopulation: TS-SRD and TS-BA
Terminal half-life of the analyte in plasma (t1/2).
Outcome measures
| Measure |
BI 1026706 - Tablet 25 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 50 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 100 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 400 mg (SRD - Part)
n=4 Participants
Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 10 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
|
BI 1026706 - Solution 100 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition
|
BI 1026706 - Solution 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
|
BI 1026706 - Solution 400 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
|
Placebo (SRD - Part)
n=11 Participants
Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 100 mg Fasted (R2)
n=12 Participants
Subjects were treated with 100 mg drinking solution (R2) under fasting condition.
|
BI 1026706 - 100 mg Solution Fed (T2)
n=12 Participants
Subjects were treated with 100 mg drinking solution (T2) under fed condition.
|
BI 1026706 - Tablet 100 mg Fasted (R1)
n=10 Participants
Subjects were treated with 100mg film coated tablet (R1) under fasted condition.
|
BI 1026706 - Tablet 100 mg Fed (T1)
Subjects were treated with 100mg film coated tablet (T1) under fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
t1/2 (Terminal Half-life of the Analyte in Plasma)
|
10.80 hours
Geometric Coefficient of Variation 75.7
|
8.58 hours
Geometric Coefficient of Variation 54.3
|
12.10 hours
Geometric Coefficient of Variation 26.6
|
11.60 hours
Geometric Coefficient of Variation 43.2
|
12.00 hours
Geometric Coefficient of Variation 22.7
|
13.90 hours
Geometric Coefficient of Variation 82.1
|
12.80 hours
Geometric Coefficient of Variation 54.7
|
11.50 hours
Geometric Coefficient of Variation 50.3
|
9.29 hours
Geometric Coefficient of Variation 27.3
|
10.80 hours
Geometric Coefficient of Variation 36.0
|
11.10 hours
Geometric Coefficient of Variation 53.9
|
10.50 hours
Geometric Coefficient of Variation 46.9
|
12.60 hours
Geometric Coefficient of Variation 28.4
|
—
|
SECONDARY outcome
Timeframe: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hoursPopulation: TS-SRD
Fraction of analyte eliminated in urine from the time point t1 (0h) to time point t2 (72h) (f t1-t2).
Outcome measures
| Measure |
BI 1026706 - Tablet 25 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 50 mg (SRD - Part)
n=4 Participants
Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 100 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 400 mg (SRD - Part)
n=4 Participants
Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 10 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
|
BI 1026706 - Solution 100 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition
|
BI 1026706 - Solution 200 mg (SRD - Part)
n=6 Participants
Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
|
BI 1026706 - Solution 400 mg (SRD - Part)
n=5 Participants
Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
|
Placebo (SRD - Part)
Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 100 mg Fasted (R2)
Subjects were treated with 100 mg drinking solution (R2) under fasting condition.
|
BI 1026706 - 100 mg Solution Fed (T2)
Subjects were treated with 100 mg drinking solution (T2) under fed condition.
|
BI 1026706 - Tablet 100 mg Fasted (R1)
Subjects were treated with 100mg film coated tablet (R1) under fasted condition.
|
BI 1026706 - Tablet 100 mg Fed (T1)
Subjects were treated with 100mg film coated tablet (T1) under fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
f t1-t2 (SRD-Part)
|
3.02 Percentage
Geometric Coefficient of Variation 21.1
|
2.75 Percentage
Geometric Coefficient of Variation 51.2
|
3.43 Percentage
Geometric Coefficient of Variation 33.4
|
1.95 Percentage
Geometric Coefficient of Variation 27.2
|
1.87 Percentage
Geometric Coefficient of Variation 45.3
|
3.97 Percentage
Geometric Coefficient of Variation 40.8
|
3.47 Percentage
Geometric Coefficient of Variation 23.9
|
3.82 Percentage
Geometric Coefficient of Variation 32.8
|
2.09 Percentage
Geometric Coefficient of Variation 7.44
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
BI 1026706 - Tablet 25 mg (SRD - Part)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 1026706 - Tablet 50 mg (SRD - Part)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 1026706 - Tablet 100 mg (SRD - Part)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1026706 - Tablet 200 mg (SRD - Part)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1026706 - Tablet 400 mg (SRD - Part)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1026706 - Solution 10 mg (SRD - Part)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1026706 - Solution 100 mg (SRD - Part)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1026706 - Solution 200 mg (SRD - Part)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 1026706 - Solution 400 mg (SRD - Part)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo (SRD - Part)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
BI 1026706 - Solution 100 mg Fasted (R2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1026706 - 100 mg Solution Fed (T2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1026706 - Tablet 100 mg Fasted (R1)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 1026706 - Tablet 100 mg Fed (T1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1026706 - Tablet 25 mg (SRD - Part)
n=6 participants at risk
Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 50 mg (SRD - Part)
n=6 participants at risk
Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 100 mg (SRD - Part)
n=6 participants at risk
Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 200 mg (SRD - Part)
n=6 participants at risk
Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Tablet 400 mg (SRD - Part)
n=4 participants at risk
Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 10 mg (SRD - Part)
n=6 participants at risk
Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.
|
BI 1026706 - Solution 100 mg (SRD - Part)
n=5 participants at risk
Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition.
|
BI 1026706 - Solution 200 mg (SRD - Part)
n=6 participants at risk
Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.
|
BI 1026706 - Solution 400 mg (SRD - Part)
n=5 participants at risk
Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.
|
Placebo (SRD - Part)
n=18 participants at risk
Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.
|
BI 1026706 - Solution 100 mg Fasted (R2)
n=11 participants at risk
Subjects were treated with 100 mg drinking solution (R2) under fasting condition.
|
BI 1026706 - 100 mg Solution Fed (T2)
n=12 participants at risk
Subjects were treated with 100 mg drinking solution (T2) under fed condition.
|
BI 1026706 - Tablet 100 mg Fasted (R1)
n=12 participants at risk
Subjects were treated with 100mg film coated tablet (R1) under fasted condition.
|
BI 1026706 - Tablet 100 mg Fed (T1)
n=10 participants at risk
Subjects were treated with 100mg film coated tablet (T1) under fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
10.0%
1/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
9.1%
1/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
40.0%
2/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
8.3%
1/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
40.0%
2/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
8.3%
1/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
8.3%
1/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
20.0%
1/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
General disorders
Application site haematoma
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
8.3%
1/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
33.3%
2/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
20.0%
1/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
22.2%
4/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
5.6%
1/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Investigations
Heart rate increased
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
10.0%
1/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Investigations
Platelet count increased
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
8.3%
1/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
25.0%
1/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
9.1%
1/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
20.0%
1/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
5.6%
1/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
8.3%
1/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
33.3%
2/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
40.0%
2/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
3/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
9.1%
1/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
8.3%
1/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
25.0%
3/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
20.0%
2/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
25.0%
1/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
5.6%
1/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
10.0%
1/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
2/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
8.3%
1/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
16.7%
1/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
5.6%
1/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
33.3%
2/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/4 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/6 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/5 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/18 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/11 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/12 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
0.00%
0/10 • From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place