Trial Outcomes & Findings for Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects (NCT NCT03329573)
NCT ID: NCT03329573
Last Updated: 2020-03-27
Results Overview
Blood samples were collected at designated time points. Pharmacokinetic (PK) parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of bioequivalence (BE). Point estimate and associated adjusted 90% confidence interval (CI) of difference between both the treatments were provided for AUC(0-infinity).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
85 participants
Primary outcome timeframe
Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
Results posted on
2020-03-27
Participant Flow
This was a single dose, open-label, randomized, two-period crossover study to demonstrate the bioequivalence of Paroxetine immediate release (IR) tablets manufactured in GlaxoSmithKline Tianjin (GSKT) (A) and Mississauga (B) sites in healthy Chinese participants under fasting and fed conditions.
Participants received treatment in one of the two sequences; treatment A (GSKT, Paroxetine IR investigational drug) followed by treatment B (Mississauga, Paroxetine IR reference drug) or vice versa in each of the treatment period 1 and 2. A total of 85 (47 under fed condition and 38 under fasting condition) participants were enrolled.
Participant milestones
| Measure |
Paroxetine 40 mg, GSKT Followed by Mississauga- Fed
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg\*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.
|
Paroxetine 40 mg, Mississauga Followed by GSKT- Fed
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.
|
Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg\*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.
|
Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.
|
|---|---|---|---|---|
|
Treatment Period 1 (Up to 5 Days)
STARTED
|
23
|
24
|
19
|
19
|
|
Treatment Period 1 (Up to 5 Days)
COMPLETED
|
22
|
21
|
19
|
19
|
|
Treatment Period 1 (Up to 5 Days)
NOT COMPLETED
|
1
|
3
|
0
|
0
|
|
Washout Period (Day 6 to Day 11)
STARTED
|
22
|
21
|
19
|
19
|
|
Washout Period (Day 6 to Day 11)
COMPLETED
|
22
|
21
|
19
|
19
|
|
Washout Period (Day 6 to Day 11)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (Day 12 to Day 26)
STARTED
|
22
|
21
|
19
|
19
|
|
Treatment Period 2 (Day 12 to Day 26)
COMPLETED
|
21
|
20
|
19
|
19
|
|
Treatment Period 2 (Day 12 to Day 26)
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Paroxetine 40 mg, GSKT Followed by Mississauga- Fed
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg\*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.
|
Paroxetine 40 mg, Mississauga Followed by GSKT- Fed
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.
|
Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg\*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.
|
Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.
|
|---|---|---|---|---|
|
Treatment Period 1 (Up to 5 Days)
Adverse Event
|
0
|
1
|
0
|
0
|
|
Treatment Period 1 (Up to 5 Days)
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
|
Treatment Period 2 (Day 12 to Day 26)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Treatment Period 2 (Day 12 to Day 26)
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects
Baseline characteristics by cohort
| Measure |
Paroxetine 40 mg, GSKT Followed by Mississauga- Fed
n=23 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg\*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.
|
Paroxetine 40 mg, Mississauga Followed by GSKT- Fed
n=24 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.
|
Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted
n=19 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg\*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.
|
Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted
n=19 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.3 Years
STANDARD_DEVIATION 7.53 • n=5 Participants
|
27.1 Years
STANDARD_DEVIATION 5.63 • n=7 Participants
|
25.4 Years
STANDARD_DEVIATION 5.86 • n=5 Participants
|
28.1 Years
STANDARD_DEVIATION 6.17 • n=4 Participants
|
27.3 Years
STANDARD_DEVIATION 6.46 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian - East Asian Heritage
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment periodPopulation: BE analysis Population. BE analysis Population comprised of all randomized participants who completed all the planned treatments and provided at least one evaluable primary PK parameter data from both period 1 and period 2. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at designated time points. Pharmacokinetic (PK) parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of bioequivalence (BE). Point estimate and associated adjusted 90% confidence interval (CI) of difference between both the treatments were provided for AUC(0-infinity).
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=40 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=40 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
|
860.54 Hour*nanogram per milliliter
Interval 728.07 to 1017.12
|
812.49 Hour*nanogram per milliliter
Interval 687.42 to 960.33
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment periodPopulation: BE analysis Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-infinity).
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=36 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=36 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
AUC(0-infinity) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
|
742.07 Hour*nanogram per milliliter
Interval 615.82 to 894.21
|
745.22 Hour*nanogram per milliliter
Interval 618.43 to 898.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment periodPopulation: BE analysis Population
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=41 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=41 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Administration Extrapolated to the Last Time of Quantifiable Concentration (AUC[0-t]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
|
866.85 Hour*nanogram per milliliter
Interval 733.56 to 1024.36
|
814.75 Hour*nanogram per milliliter
Interval 689.47 to 962.8
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment periodPopulation: BE analysis Population
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=37 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=37 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
AUC(0-t) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
|
750.49 Hour*nanogram per milliliter
Interval 623.3 to 903.64
|
753.83 Hour*nanogram per milliliter
Interval 626.08 to 907.66
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment periodPopulation: BE analysis Population
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=41 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=41 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Maximum Observed Concentration (Cmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
|
39.95 Nanogram per milliliter
Interval 35.36 to 45.14
|
39.02 Nanogram per milliliter
Interval 34.54 to 44.09
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment periodPopulation: BE analysis Population.
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=37 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=37 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Cmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
|
36.86 Nanogram per milliliter
Interval 32.73 to 41.52
|
36.15 Nanogram per milliliter
Interval 32.1 to 40.72
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. PK Population comprised of all randomized participants received at least one dose of study treatment and provided at least one evaluable PK concentration data. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=43 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=45 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Time to Reach Maximum Observed Concentration (Tmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
|
5.00 Hours
Interval 2.0 to 8.1
|
5.00 Hours
Interval 2.0 to 8.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=38 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=37 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Tmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
|
5.00 Hours
Interval 2.0 to 8.0
|
5.00 Hours
Interval 2.0 to 8.1
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=43 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=45 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Terminal Elimination Rate Constant (Lambda z) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
|
0.0433 Per hour
Interval 0.0385 to 0.0487
|
0.0462 Per hour
Interval 0.0422 to 0.0507
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=38 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=37 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Lambda z of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
|
0.0483 Per hour
Interval 0.0444 to 0.0525
|
0.0494 Per hour
Interval 0.0451 to 0.0541
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=43 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=45 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
|
16.0002 Hours
Interval 14.2232 to 17.9992
|
14.9913 Hours
Interval 13.685 to 16.4223
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=38 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=37 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
t1/2 of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
|
14.3515 Hours
Interval 13.2046 to 15.598
|
14.0311 Hours
Interval 12.806 to 15.3734
|
SECONDARY outcome
Timeframe: Up to Day 26Population: Safety Population. Safety Population comprised of all randomized participants who received at least one dose of study treatment. Only those participants with data available at the specified data points were analyzed.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=44 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=46 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition
Any non-SAEs
|
14 Participants
|
13 Participants
|
|
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition
Any SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 26Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=38 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=38 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Number of Participants With Non-SAE and SAEs Under Fasting Condition
Any non-SAEs
|
12 Participants
|
16 Participants
|
|
Number of Participants With Non-SAE and SAEs Under Fasting Condition
Any SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 16Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to analyze the clinical chemistry laboratory parameters; alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST),calcium,creatinine, glucose, potassium (Pot) and sodium. PCI ranges were ALT (high: \>=2 times upper limit of normal \[ULN\] units per liter \[U/L\]),albumin (low: \<30 grams per liter),ALP (low: \<20 international units per liter \[IU/L\] and high: \>200 IU/L), AST (high: \>=2 times ULN U/L),calcium (low: \<2 millimoles per liter \[mmol/L\] and high: \>2.75 mmol/L),creatinine (high: \>133 micromoles per liter), glucose (low: \<3 mmol/L and high: \>9 mmol/L), Pot (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=22 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=22 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Pot, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Sodium, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Sodium, To normal or no change
|
22 Participants
|
22 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Sodium, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
ALT, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
ALT, To normal or no change
|
22 Participants
|
22 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
ALT, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Albumin, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Albumin, To normal or no change
|
22 Participants
|
22 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Albumin, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
ALP, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
ALP, To normal or no change
|
22 Participants
|
22 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
ALP, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
AST, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
AST, To normal or no change
|
22 Participants
|
22 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
AST, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Calcium, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Calcium, To normal or no change
|
22 Participants
|
22 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Calcium, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Creatinine, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Creatinine, To normal or no change
|
22 Participants
|
22 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Creatinine, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Glucose, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Glucose, To normal or no change
|
22 Participants
|
22 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Glucose, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Pot, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Pot, To normal or no change
|
22 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Day 16Population: Safety Population
Blood samples were collected to analyze the clinical chemistry laboratory parameters; ALT, albumin, ALP, AST, calcium, creatinine, glucose, Pot and sodium. PCI ranges were ALT (high: \>=2 times ULN U/L), albumin (low: \<30 grams per liter), ALP (low: \<20 IU/L and high: \>200 IU/L), AST (high: \>=2 times ULN U/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), creatinine (high: \>133 micromoles per liter), glucose (low: \<3 mmol/L and high: \>9 mmol/L), Pot (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=19 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=19 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
ALT, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
ALT, To normal or no change
|
19 Participants
|
19 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
ALT, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Albumin, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Albumin, To normal or no change
|
19 Participants
|
19 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Albumin, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
ALP, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
ALP, To normal or no change
|
19 Participants
|
19 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
ALP, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
AST, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
AST, To normal or no change
|
19 Participants
|
19 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
AST, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Calcium, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Calcium, To normal or no change
|
19 Participants
|
19 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Calcium, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Creatinine, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Creatinine, To normal or no change
|
19 Participants
|
19 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Creatinine, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Glucose, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Glucose, To normal or no change
|
19 Participants
|
19 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Glucose, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Pot, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Pot, To normal or no change
|
19 Participants
|
19 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Pot, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Sodium, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Sodium, To normal or no change
|
19 Participants
|
19 Participants
|
|
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Sodium, To high
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 16Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to analyze; hematocrit(Hct),hemoglobin(Hb),erythrocytes and platelets. PCI ranges; Hct(Male\[low: \<0.03 proportion of red blood cells in blood and high: \>0.54 proportion of red blood cells in blood\] and Female\[low: \<0.04 proportion of red blood cells in blood and high: \>0.54 proportion of red blood cells in blood\]),Hb(Male \[low: \<110 grams per liter and high: \>180 grams per liter) and Female\[low: \<100 grams per liter and high: \>170 grams per liter\]),erythrocytes(Male \[low: \<4.5x10\^12 cells per liter and high: \>5.5x10\^12 cells per liter\] and Female\[low: \<4 x10\^12 cells per liter and high: \>5 x10\^12 cells per liter\]) and platelets(low: \<80x10\^9 cells per liter and high: \>400x10\^9 cells per liter). Participants were counted in the category that their value changed to(low, normal or high). If values were unchanged(example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category.Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=22 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=22 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Erythrocytes, To low
|
2 Participants
|
2 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Erythrocytes, To normal or no change
|
20 Participants
|
19 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Erythrocytes, To high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Hct, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Hct, To normal or no change
|
22 Participants
|
22 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Hct, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Hb, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Hb, To normal or no change
|
22 Participants
|
22 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Hb, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Platelets, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Platelets, To normal or no change
|
22 Participants
|
22 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Platelets, To high
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 16Population: Safety Population
Blood samples were collected to analyze; Hct, Hb, erythrocytes and platelets. PCI ranges were Hct (Male \[low: \<0.03 proportion of red blood cells in blood and high: \>0.54 proportion of red blood cells in blood\] and Female \[low: \<0.04 proportion of red blood cells in blood and high: \>0.54 proportion of red blood cells in blood\]), Hb (Male \[low: \<110 grams per liter and high: \>180 grams per liter) and Female \[low: \<100 grams per liter and high: \>170 grams per liter\]), erythrocytes (Male \[low: \<4.5x10\^12 cells per liter and high: \>5.5x10\^12 cells per liter\] and Female \[low: \<4 x10\^12 cells per liter and high: \>5 x10\^12 cells per liter\]) and platelets (low: \<80x10\^9 cells per liter and high: \>400x10\^9 cells per liter). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=19 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=19 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Erythrocytes, To low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Erythrocytes, To normal or no change
|
18 Participants
|
19 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Erythrocytes, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Hct, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Hct, To normal or no change
|
19 Participants
|
19 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Hct, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Hb, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Hb, To normal or no change
|
19 Participants
|
19 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Hb, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Platelets, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Platelets, To normal or no change
|
19 Participants
|
19 Participants
|
|
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Platelets, To high
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day-7 to Day -1) and Day 16Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine potential of hydrogen (pH). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=22 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=25 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Glucose, Baseline, Negative, n=22,25
|
22 Participants
|
25 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Glucose, Baseline, Positive, n=22,25
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Glucose, Day 16, Negative, n=22,22
|
22 Participants
|
22 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Glucose, Day 16, Positive, n=22,22
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Ketones, Baseline, Positive, n=22,25
|
2 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Ketones, Baseline, Negative, n=22,25
|
20 Participants
|
24 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Ketones, Day 16, Positive,n=22,22
|
1 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Ketones, Day 16, Negative,n=22,22
|
21 Participants
|
22 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Occult blood, Baseline, Positive,n=22,25
|
2 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Occult blood, Baseline, Negative,n=22,25
|
20 Participants
|
22 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Occult blood, Day 16, Positive,n=22,22
|
5 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Occult blood, Day 16, Negative,n=22,22
|
17 Participants
|
19 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Protein, Baseline, Negative,n=22,25
|
22 Participants
|
25 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Protein, Baseline, Positive,n=22,25
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Protein, Day 16, Positive,n=22,22
|
1 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Protein, Day 16, Negative,n=22,22
|
21 Participants
|
22 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
pH=5, Baseline,n=22,25
|
1 Participants
|
4 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
pH=6, Baseline,n=22,25
|
7 Participants
|
5 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
pH=6.5, Baseline,n=22,25
|
3 Participants
|
6 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
pH=7, Baseline,n=22,25
|
9 Participants
|
10 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
pH=8, Baseline,n=22,25
|
2 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
pH=5, Day 16,n=22,22
|
2 Participants
|
4 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
pH=6, Day 16,n=22,22
|
12 Participants
|
10 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
pH=6.5, Day 16,n=22,22
|
4 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
pH=7, Day 16,n=22,22
|
4 Participants
|
6 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
pH=8, Day 16,n=22,22
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day-7 to Day -1) and Day 16Population: Safety Population
Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine pH. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=19 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=19 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Glucose, Baseline, Negative,
|
19 Participants
|
19 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Glucose, Baseline, Positive,
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Glucose, Day 16, Negative,
|
19 Participants
|
19 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Glucose, Day 16, Positive,
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Ketones, Baseline, Negative
|
19 Participants
|
19 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Ketones, Baseline, Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Ketones, Day 16,Positive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Ketones, Day 16, Negative
|
18 Participants
|
18 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Occult blood, Baseline, Positive
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Occult blood, Baseline, Negative
|
19 Participants
|
18 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Occult blood, Day 16, Positive
|
3 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Occult blood, Day 16, Negative
|
16 Participants
|
18 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Protein, Baseline, Negative
|
19 Participants
|
19 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Protein, Baseline, Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Protein, Day 16, Positive
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Protein, Day 16, Negative
|
19 Participants
|
18 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
pH=5, Baseline
|
3 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
pH=6, Baseline
|
2 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
pH=6.5, Baseline
|
5 Participants
|
4 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
pH=7, Baseline
|
6 Participants
|
9 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
pH=8, Baseline
|
3 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
pH=5, Day 16
|
4 Participants
|
6 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
pH=6, Day 16
|
13 Participants
|
11 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
pH=6.5, Day 16
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
pH=7, Day 16
|
2 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
pH=8, Day 16
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day-7 to Day -1) and Day 16Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QT corrected (QTc) intervals. Clinically significant abnormal ranges were: heart rate: lower:\<50 beats per minute and upper: \>110 beats per minute; QT: Upper: \>400 milliseconds (msec); QTc: Upper: \>450 msec; PR: lower: \<110 msec and upper: \>220 msec; QRS: lower: \<60 msec and upper: \>120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=22 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=25 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition
Baseline, n=22, 25
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition
Day 16, n=22, 22
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day-7 to Day -1) and Day 16Population: Safety Population
A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc intervals. Clinically significant abnormal ranges were: heart rate: lower :\<50 beats per minute and upper: \>110 beats per minute; QT: Upper: \>400 msec; QTc: Upper: \>450 msec; PR: lower: \<110 msec and upper: \>220 msec; QRS: lower: \<60 msec and upper: \>120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=19 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=19 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition
Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition
Day 16
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=23 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=24 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
DBP, Day 1 (post-dose), n=23,24
|
70.4 Millimeters of mercury
Standard Deviation 9.27
|
67.8 Millimeters of mercury
Standard Deviation 6.84
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
DBP, Day 2 (post-dose), n=23,24
|
69.0 Millimeters of mercury
Standard Deviation 7.93
|
66.8 Millimeters of mercury
Standard Deviation 7.38
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
DBP, Day 3, n=23,24
|
67.7 Millimeters of mercury
Standard Deviation 7.11
|
64.5 Millimeters of mercury
Standard Deviation 5.27
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
DBP, Day 4, n=23,24
|
67.5 Millimeters of mercury
Standard Deviation 6.68
|
66.1 Millimeters of mercury
Standard Deviation 6.86
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
DBP, Day 5, n=23,24
|
69.7 Millimeters of mercury
Standard Deviation 6.98
|
68.9 Millimeters of mercury
Standard Deviation 7.31
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
DBP, Day 11, n=21,22
|
69.9 Millimeters of mercury
Standard Deviation 7.62
|
70.5 Millimeters of mercury
Standard Deviation 8.98
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
DBP, Day 12 (pre-dose), n=21,22
|
71.2 Millimeters of mercury
Standard Deviation 6.59
|
72.7 Millimeters of mercury
Standard Deviation 7.79
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
DBP, Day 12 (post-dose), n=20,22
|
69.9 Millimeters of mercury
Standard Deviation 7.71
|
72.2 Millimeters of mercury
Standard Deviation 7.67
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
DBP, Day 13 (post-dose), n=20,22
|
70.3 Millimeters of mercury
Standard Deviation 6.50
|
72.9 Millimeters of mercury
Standard Deviation 7.75
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
DBP, Day 14, n=20,22
|
70.3 Millimeters of mercury
Standard Deviation 8.15
|
71.7 Millimeters of mercury
Standard Deviation 7.09
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
DBP, Day 15, n=20,22
|
68.8 Millimeters of mercury
Standard Deviation 6.14
|
70.4 Millimeters of mercury
Standard Deviation 7.10
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
DBP, Day 16, n=20,22
|
72.8 Millimeters of mercury
Standard Deviation 8.42
|
73.9 Millimeters of mercury
Standard Deviation 6.65
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
SBP, Day 1 (post-dose), n=23,24
|
112.4 Millimeters of mercury
Standard Deviation 10.13
|
111.8 Millimeters of mercury
Standard Deviation 11.15
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
SBP, Day 2 (post-dose), n=23,24
|
113.8 Millimeters of mercury
Standard Deviation 9.07
|
111.0 Millimeters of mercury
Standard Deviation 10.19
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
SBP, Day 3, n=23,24
|
112.9 Millimeters of mercury
Standard Deviation 9.46
|
109.4 Millimeters of mercury
Standard Deviation 10.52
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
SBP, Day 4, n=23,24
|
111.1 Millimeters of mercury
Standard Deviation 10.83
|
110.9 Millimeters of mercury
Standard Deviation 10.97
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
SBP, Day 5, n=23,24
|
109.2 Millimeters of mercury
Standard Deviation 10.31
|
109.8 Millimeters of mercury
Standard Deviation 10.08
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
SBP, Day 11, n=21,22
|
109.0 Millimeters of mercury
Standard Deviation 10.89
|
110.6 Millimeters of mercury
Standard Deviation 9.18
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
SBP, Day 12 (pre-dose), n=21,22
|
107.2 Millimeters of mercury
Standard Deviation 9.54
|
108.5 Millimeters of mercury
Standard Deviation 8.34
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
SBP, Day 12 (post-dose), n=20,22
|
112.4 Millimeters of mercury
Standard Deviation 9.66
|
112.4 Millimeters of mercury
Standard Deviation 11.42
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
SBP, Day 13 (post-dose), n=20,22
|
111.4 Millimeters of mercury
Standard Deviation 10.18
|
112.0 Millimeters of mercury
Standard Deviation 8.80
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
SBP, Day 14, n=20,22
|
107.0 Millimeters of mercury
Standard Deviation 9.49
|
105.5 Millimeters of mercury
Standard Deviation 8.44
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
SBP, Day 15, n=20,22
|
107.3 Millimeters of mercury
Standard Deviation 7.73
|
106.0 Millimeters of mercury
Standard Deviation 9.62
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
SBP, Day 16, n=20,22
|
107.1 Millimeters of mercury
Standard Deviation 8.94
|
105.9 Millimeters of mercury
Standard Deviation 6.29
|
SECONDARY outcome
Timeframe: Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16Population: Safety Population
Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=19 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=19 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
DBP, Day 1 (post-dose)
|
71.8 Millimeters of mercury
Standard Deviation 6.37
|
70.9 Millimeters of mercury
Standard Deviation 6.56
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
DBP, Day 2 (post-dose)
|
68.3 Millimeters of mercury
Standard Deviation 7.59
|
68.7 Millimeters of mercury
Standard Deviation 7.61
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
DBP, Day 3
|
66.2 Millimeters of mercury
Standard Deviation 6.99
|
67.8 Millimeters of mercury
Standard Deviation 9.22
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
DBP, Day 4
|
68.3 Millimeters of mercury
Standard Deviation 8.29
|
68.8 Millimeters of mercury
Standard Deviation 5.91
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
DBP, Day 5
|
68.1 Millimeters of mercury
Standard Deviation 6.16
|
73.3 Millimeters of mercury
Standard Deviation 7.31
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
DBP, Day 11
|
71.9 Millimeters of mercury
Standard Deviation 6.62
|
71.4 Millimeters of mercury
Standard Deviation 7.36
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
DBP, Day 12 (pre-dose)
|
72.6 Millimeters of mercury
Standard Deviation 8.00
|
71.2 Millimeters of mercury
Standard Deviation 9.11
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
DBP, Day 12 (post-dose)
|
73.5 Millimeters of mercury
Standard Deviation 6.29
|
70.3 Millimeters of mercury
Standard Deviation 7.59
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
DBP, Day 13 (post-dose)
|
72.6 Millimeters of mercury
Standard Deviation 6.72
|
69.6 Millimeters of mercury
Standard Deviation 7.22
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
DBP, Day 14
|
72.2 Millimeters of mercury
Standard Deviation 6.96
|
70.2 Millimeters of mercury
Standard Deviation 4.76
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
DBP, Day 15
|
70.6 Millimeters of mercury
Standard Deviation 7.65
|
68.7 Millimeters of mercury
Standard Deviation 8.39
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
DBP, Day 16
|
71.9 Millimeters of mercury
Standard Deviation 7.32
|
71.1 Millimeters of mercury
Standard Deviation 8.28
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
SBP, Day 1 (post-dose)
|
107.4 Millimeters of mercury
Standard Deviation 10.56
|
109.2 Millimeters of mercury
Standard Deviation 10.82
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
SBP, Day 2 (post-dose)
|
108.1 Millimeters of mercury
Standard Deviation 11.85
|
110.1 Millimeters of mercury
Standard Deviation 10.13
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
SBP, Day 3
|
106.3 Millimeters of mercury
Standard Deviation 10.19
|
108.2 Millimeters of mercury
Standard Deviation 12.21
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
SBP, Day 4
|
105.1 Millimeters of mercury
Standard Deviation 10.31
|
107.4 Millimeters of mercury
Standard Deviation 8.78
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
SBP, Day 5
|
104.4 Millimeters of mercury
Standard Deviation 9.17
|
111.3 Millimeters of mercury
Standard Deviation 12.03
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
SBP, Day 11
|
113.2 Millimeters of mercury
Standard Deviation 13.72
|
111.4 Millimeters of mercury
Standard Deviation 12.88
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
SBP, Day 12 (pre-dose)
|
108.3 Millimeters of mercury
Standard Deviation 10.40
|
107.4 Millimeters of mercury
Standard Deviation 9.63
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
SBP, Day 12 (post-dose)
|
111.6 Millimeters of mercury
Standard Deviation 9.63
|
107.5 Millimeters of mercury
Standard Deviation 8.84
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
SBP, Day 13 (post-dose)
|
111.7 Millimeters of mercury
Standard Deviation 10.50
|
109.9 Millimeters of mercury
Standard Deviation 11.86
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
SBP, Day 14
|
110.5 Millimeters of mercury
Standard Deviation 12.18
|
104.5 Millimeters of mercury
Standard Deviation 9.48
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
SBP, Day 15
|
108.5 Millimeters of mercury
Standard Deviation 10.56
|
107.4 Millimeters of mercury
Standard Deviation 9.63
|
|
DBP and SBP at Indicated Time-points Under Fasting Condition
SBP, Day 16
|
110.7 Millimeters of mercury
Standard Deviation 12.70
|
104.2 Millimeters of mercury
Standard Deviation 9.65
|
SECONDARY outcome
Timeframe: Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=23 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=24 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Day 1 (post-dose), n=23,24
|
72.3 Beats per minute
Standard Deviation 10.57
|
72.0 Beats per minute
Standard Deviation 8.83
|
|
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Day 2 (post-dose), n=23,24
|
72.8 Beats per minute
Standard Deviation 8.22
|
74.1 Beats per minute
Standard Deviation 9.98
|
|
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Day 3, n=23,24
|
74.0 Beats per minute
Standard Deviation 9.11
|
75.8 Beats per minute
Standard Deviation 10.07
|
|
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Day 4, n=23,24
|
75.5 Beats per minute
Standard Deviation 7.13
|
75.7 Beats per minute
Standard Deviation 11.02
|
|
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Day 5, n=23,24
|
68.7 Beats per minute
Standard Deviation 7.03
|
68.3 Beats per minute
Standard Deviation 8.87
|
|
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Day 11, n=21,22
|
75.0 Beats per minute
Standard Deviation 11.05
|
77.7 Beats per minute
Standard Deviation 8.38
|
|
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Day 12 (pre-dose), n=21,22
|
65.8 Beats per minute
Standard Deviation 9.00
|
64.7 Beats per minute
Standard Deviation 7.57
|
|
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Day 12 (post-dose), n=20,22
|
72.8 Beats per minute
Standard Deviation 10.85
|
76.2 Beats per minute
Standard Deviation 10.15
|
|
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Day 13 (post-dose), n=20,22
|
73.7 Beats per minute
Standard Deviation 11.86
|
73.8 Beats per minute
Standard Deviation 8.07
|
|
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Day 14, n=20,22
|
75.6 Beats per minute
Standard Deviation 10.72
|
77.6 Beats per minute
Standard Deviation 9.88
|
|
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Day 15, n=20,22
|
77.5 Beats per minute
Standard Deviation 11.33
|
75.5 Beats per minute
Standard Deviation 8.38
|
|
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Day 16, n=20,22
|
69.4 Beats per minute
Standard Deviation 8.54
|
72.6 Beats per minute
Standard Deviation 9.51
|
SECONDARY outcome
Timeframe: Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16Population: Safety Population
Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=19 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=19 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Day 1 (post-dose)
|
65.4 Beats per minute
Standard Deviation 8.80
|
67.5 Beats per minute
Standard Deviation 7.19
|
|
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Day 2 (post-dose)
|
74.8 Beats per minute
Standard Deviation 7.40
|
75.3 Beats per minute
Standard Deviation 8.31
|
|
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Day 3
|
74.9 Beats per minute
Standard Deviation 8.45
|
77.2 Beats per minute
Standard Deviation 10.69
|
|
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Day 4
|
74.2 Beats per minute
Standard Deviation 8.74
|
72.8 Beats per minute
Standard Deviation 9.86
|
|
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Day 5
|
67.3 Beats per minute
Standard Deviation 6.82
|
71.2 Beats per minute
Standard Deviation 9.60
|
|
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Day 11
|
81.8 Beats per minute
Standard Deviation 9.72
|
84.1 Beats per minute
Standard Deviation 9.20
|
|
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Day 12 (pre-dose)
|
66.5 Beats per minute
Standard Deviation 8.73
|
66.8 Beats per minute
Standard Deviation 10.48
|
|
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Day 12 (post-dose)
|
67.5 Beats per minute
Standard Deviation 8.96
|
65.2 Beats per minute
Standard Deviation 7.19
|
|
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Day 13 (post-dose)
|
78.1 Beats per minute
Standard Deviation 11.03
|
75.4 Beats per minute
Standard Deviation 7.54
|
|
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Day 14
|
78.9 Beats per minute
Standard Deviation 11.12
|
76.8 Beats per minute
Standard Deviation 8.25
|
|
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Day 15
|
78.2 Beats per minute
Standard Deviation 8.38
|
75.9 Beats per minute
Standard Deviation 9.58
|
|
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Day 16
|
75.7 Beats per minute
Standard Deviation 10.39
|
71.3 Beats per minute
Standard Deviation 7.92
|
SECONDARY outcome
Timeframe: Day 11Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=21 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=22 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Respiratory Rate (RR) at Indicated Time-point Under Fed Condition
|
17.8 Breaths per minute
Standard Deviation 1.78
|
18.6 Breaths per minute
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Day 11Population: Safety Population
Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=19 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=19 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
RR at Indicated Time-point Under Fasting Condition
|
19.2 Breaths per minute
Standard Deviation 1.38
|
19.4 Breaths per minute
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Day 11Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=21 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=22 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Temperature at Indicated Time-point Under Fed Condition
|
36.70 Celsius
Standard Deviation 0.307
|
36.59 Celsius
Standard Deviation 0.333
|
SECONDARY outcome
Timeframe: Day 11Population: Safety Population
Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Outcome measures
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=19 Participants
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=19 Participants
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
|---|---|---|
|
Temperature at Indicated Time-point Under Fasting Condition
|
36.84 Celsius
Standard Deviation 0.187
|
36.74 Celsius
Standard Deviation 0.256
|
Adverse Events
Paroxetine 40 mg, GSKT- Fed
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Paroxetine 40 mg, Mississauga- Fed
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Paroxetine 40 mg, GSKT- Fasted
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Paroxetine 40 mg, Mississauga- Fasted
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paroxetine 40 mg, GSKT- Fed
n=44 participants at risk
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, Mississauga- Fed
n=46 participants at risk
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
|
Paroxetine 40 mg, GSKT- Fasted
n=38 participants at risk
Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
|
Paroxetine 40 mg, Mississauga- Fasted
n=38 participants at risk
Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
|
|---|---|---|---|---|
|
Investigations
Protein urine present
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Urine ketone body present
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.3%
2/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Bacterial test
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.2%
1/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.3%
2/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
White blood cells urine positive
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.2%
1/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
7.9%
3/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
7.9%
3/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood uric acid increased
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood urine present
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Occult blood positive
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
6.5%
3/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.2%
1/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.2%
1/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.2%
1/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.2%
1/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
4.3%
2/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.3%
2/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.2%
1/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
13.2%
5/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
15.8%
6/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.3%
2/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
4.3%
2/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Mouth swelling
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.2%
1/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.2%
1/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
4.5%
2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
13.2%
5/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
15.8%
6/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
10.5%
4/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
4.3%
2/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.2%
1/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.2%
1/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.2%
1/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Vision blurred
|
2.3%
1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Mean cell haemoglobin decreased
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Mean cell volume decreased
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
White blood cell count increased
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.6%
1/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Bacterial test positive
|
0.00%
0/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/46 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.3%
2/38 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.
SAEs and Non-SAEs were reported as per the treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER