Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fed Condition
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01630902|
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : June 28, 2012
Primary objective of the present study was to compare the single dose bioavailability of Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were separated by a washout period of 21 days during fasting study.
Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Torrent's Felodipine Extended-Release Tablets||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||An Open Label, Randomised, 2-period, 2-treatment, 2-sequence, Cross-over, Single-dose Bioequivalence Study of Felodipine Extended-Release Tablets USP 10 mg (Test, Torrent Pharmaceuticals Ltd., India) Versus Felodipine Extended-Release Tablets USP 10 mg (Reference, Mylan Pharmaceuticals Inc., USA) in Healthy Human Volunteers Under Fed Condition|
- 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): NCT01630902
|Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.|
|Village Bhat, Gandhinagar, Gujarat, India|