Trial Outcomes & Findings for Paroxetine Hydrochloride 40 mg Tablets Under Fasting Conditions (NCT NCT00841698)
NCT ID: NCT00841698
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Blood samples collected over 120 hour period
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Paroxetine (Test) First
Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
|
Paxil® (Reference First)
Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
25
|
25
|
|
First Intervention
COMPLETED
|
24
|
25
|
|
First Intervention
NOT COMPLETED
|
1
|
0
|
|
Washout: 2 Weeks
STARTED
|
24
|
25
|
|
Washout: 2 Weeks
COMPLETED
|
24
|
25
|
|
Washout: 2 Weeks
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
24
|
25
|
|
Second Intervention
COMPLETED
|
24
|
25
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Paroxetine (Test) First
Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
|
Paxil® (Reference First)
Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Paroxetine Hydrochloride 40 mg Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Paroxetine (Test) First
n=25 Participants
Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
|
Paxil® (Reference First)
n=25 Participants
Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Hispanic
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 120 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Paroxetine
n=49 Participants
Paroxetine HCl 40 mg Tablet (test) dosed in either period
|
Paxil®
n=49 Participants
Paxil 40 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration (of Paroxetine in Plasma)
|
20.39 ng/mL
Standard Deviation 12.63
|
20.67 ng/mL
Standard Deviation 12.00
|
PRIMARY outcome
Timeframe: Blood samples collected over 120 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Paroxetine
n=49 Participants
Paroxetine HCl 40 mg Tablet (test) dosed in either period
|
Paxil®
n=49 Participants
Paxil 40 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
653.84 ng*h/mL
Standard Deviation 774.21
|
673.45 ng*h/mL
Standard Deviation 782.97
|
PRIMARY outcome
Timeframe: Blood samples collected over 120 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Paroxetine
n=49 Participants
Paroxetine HCl 40 mg Tablet (test) dosed in either period
|
Paxil®
n=49 Participants
Paxil 40 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
|
602.86 ng*h/mL
Standard Deviation 650.05
|
618.14 ng*h/mL
Standard Deviation 632.70
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER