Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets (Torrent Pharmaceuticals Limited) Compared to a 10 mg Dose of Norvasc® (Pfizer) in 18 Fed, Healthy Adult Subjects
|ClinicalTrials.gov Identifier: NCT00932880|
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : July 16, 2009
- The objective of this study was to compare the rate and extent of absorption of the test formulation, amlodipine besylate 10 mg tablets (Torrent Pharmaceuticals Ltd.), with that of the marketed reference product, Norvasc® 10 mg tablets (Pfizer, Inc.), when administered under fed conditions.
- This was an open-label, randomized, two-way crossover study in which 18 healthy subjects were scheduled to receive a single dose of each of two treatments in two assigned dosing periods. Each dose administration was separated by a minimum 14-day washout period.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Amlodipine Besylate Drug: Norvasc||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||An Open-Label, Randomized, Two-Way Crossover, Single Dose Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets [Torrent Pharmaceuticals Limited,India] Compared to a 10 mg Dose of Norvasc®, [Pfizer, USA] in 18 Fed, Healthy Adult Subjects|
Drug: Amlodipine Besylate
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932880
|United States, Texas|
|CEDRA Clinical Research, LLC|
|San Antonio, Texas, United States, 78217|