NCT00834249

Venlafaxine 25 mg Tablets Under Non-Fasting Conditions

Randomized, 2-Way Crossover, Bioequivalence Study of Venlafaxine 25 mg Tablets and Effexor® 25 mg Tablets Administered as 1 x 25 mg Tablet in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (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 venlafaxine 25 mg tablets (test) versus Effexor® (reference) administered as 1 x 25 mg tablet under fed conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Venlafaxine 25 mg Tablets	1 x 25 mg, single-dose fasting
DRUG	Effexor® 25 mg Tablets	1 x 25 mg, single-dose fasting

Timeline

• Start date: 2002-12-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2009-02-03
• Last updated: 2024-08-19
• Results posted: 2009-08-18

Locations

2 sites across 1 country: Canada