Bioequivalence Study of Torrent Pharmaceutical Limited's Venlafaxine Hydrochloride ER Capsules Under Fed Conditions
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|ClinicalTrials.gov Identifier: NCT01418612|
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : August 17, 2011
The Bioequivalence studies were performed to compare the rate and extent of release of the drug substance from the two Capsule formulations containing Venlafaxine Hydrochloride Extended-Release Capsules 150mg of Torrent Pharmaceuticals Limited and the Effexor XR® (Venlafaxine Hydrochloride) Extended-Release Capsules 150mg of Wyeth Pharmaceuticals Inc., USA.
Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose Bioequivalence Study of Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test formulation, Torrent Pharmaceutical Limited., India) Versus Effexor XR® 150mg capsule (Reference formulation, Wyeth Pharmaceuticals Inc., USA) in Healthy Volunteers
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Venlafaxine Hydrochloride Extended-Release Capsules of Torrent Pharmaceuticals Limited||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||An Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose Bioequivalence Study of Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test Formulation, Torrent Pharmaceutical Limited., India) Versus Effexor XR® 150mg Capsule (Reference Formulation, Wyeth Pharmaceuticals Inc., USA) in Healthy Volunteers Under Fed Conditions|
- Bioequivalence based on Composite of PharmacokineticsBioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418612
|Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,|
|Village Bhat, Gandhinagar, Gujarat, India, 382428|