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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
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.
Details
| Lead sponsor | Teva Pharmaceuticals USA |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 18 |
| Start date | 2002-12 |
| Completion | 2002-12 |
Conditions
- Healthy
Interventions
- Venlafaxine 25 mg Tablets
- Effexor® 25 mg Tablets
Primary outcomes
- Cmax - Maximum Observed Concentration - Venlafaxine in Plasma — Blood samples collected over 24 hour period
Bioequivalence based on Cmax - AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma — Blood samples collected over 24 hour period
Bioequivalence based on AUC0-inf - AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma — Blood samples collected over 24 hour period
Bioequivalence based on AUC0-t
Countries
Canada