Paroxetine Hydrochloride 40 mg Tablets Under Fasting Conditions
- Registration Number
- NCT00841698
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 40 mg film-coated tablets (test) versus Paxil® (reference) administered as 1 x 40 mg film-coated tablet under fasting conditions.
- Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Paroxetine Paroxetine HCl Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period Paxil® Paxil® Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
- Primary Outcome Measures
Name Time Method AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) Blood samples collected over 120 hour period Bioequivalence based on AUC0-t
Cmax - Maximum Observed Concentration (of Paroxetine in Plasma) Blood samples collected over 120 hour period Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) Blood samples collected over 120 hour period Bioequivalence based on AUC0-inf
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Anapharm Inc.
🇨🇦Sainte-Foy, Quebec, Canada