NCT00841698

Paroxetine Hydrochloride 40 mg Tablets Under Fasting Conditions

Randomized, 2-Way Crossover, Bioequivalence Study of Paroxetine Hydrochloride 40 mg Film-Coated Tablets and Paxil® 40 mg Film-Coated Tablets Administered as 1 x 40 mg Film-Coated Tablet in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Paroxetine HCl	40 mg Film-Coated Tablet
DRUG	Paxil®	40 mg Film-Coated Tablet

Timeline

• Start date: 2002-10-01
• Primary completion: 2002-10-01
• Completion: 2002-10-01
• First posted: 2009-02-11
• Last updated: 2024-08-19
• Results posted: 2009-08-18

Locations

1 site across 1 country: Canada