Trial Outcomes & Findings for Paroxetine Hydrochloride 40 mg Tablets Under Fed Conditions (NCT NCT00841659)

NCT ID: NCT00841659

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 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	12	12
First Intervention COMPLETED	12	12
First Intervention NOT COMPLETED	0	0
Washout: 2 Weeks STARTED	12	12
Washout: 2 Weeks COMPLETED	11	12
Washout: 2 Weeks NOT COMPLETED	1	0
Second Intervention STARTED	11	12
Second Intervention COMPLETED	11	12
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
Washout: 2 Weeks Protocol Violation	1	0

Baseline Characteristics

Paroxetine Hydrochloride 40 mg Tablets Under Fed Conditions

Baseline characteristics by cohort

Measure	Paroxetine (Test) First n=12 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=12 Participants Paxil® 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period	Total n=24 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	12 Participants n=5 Participants	12 Participants n=7 Participants	24 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 120 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Paroxetine n=23 Participants Paroxetine HCl 40 mg Tablet (test) dosed in either period	Paxil® n=23 Participants Paxil® 40 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration (of Paroxetine in Plasma)	24.66 ng/mL Standard Deviation 13.25	24.22 ng/mL Standard Deviation 12.51

PRIMARY outcome

Timeframe: Blood samples collected over 120 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Paroxetine n=23 Participants Paroxetine HCl 40 mg Tablet (test) dosed in either period	Paxil® n=23 Participants Paxil® 40 mg Tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	797.53 ng*h/mL Standard Deviation 830.95	873.69 ng*h/mL Standard Deviation 974.14

PRIMARY outcome

Timeframe: Blood samples collected over 120 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Paroxetine n=23 Participants Paroxetine HCl 40 mg Tablet (test) dosed in either period	Paxil® n=23 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)	741.41 ng*h/mL Standard Deviation 685.80	787.19 ng*h/mL Standard Deviation 736.20

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

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