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 22 Fasted, Healthy Adult Subjects
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|ClinicalTrials.gov Identifier: NCT00932763|
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : July 17, 2009
- The objective of this study was to assess the relative bioavailability of two formulations of immediate release amlodipine 10 mg under fasted conditions, in healthy subjects.
- This was an open-label, single-dose, 2-treatment, 2-period, randomized, crossover study.Twenty-two healthy subjects were enrolled. Subjects who successfully completed the screening process checked into the research center the night before first dose. Subjects who continued to meet inclusion/exclusion criteria the morning of dose were assigned a subject number, based on the order in which they successfully completed the screening process and procedures as outlined in the study protocol. Subjects were randomly assigned to a treatment sequence and received two separate single-dose administrations of study medication, one treatment per period,according to the randomization schedule. Dosing days were separated by a washout period of at least 14 days. Subjects received each of the treatments listed below during the two treatment periods following an overnight fast of at least 10 hours: amlodipine by Torrent Pharmaceuticals Ltd. and Norvasc by Pfizer, Inc.
|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 22 Fasted, Healthy Adult Subjects|
Drug: Amlodipine besylate
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): NCT00932763
|United States, Texas|
|CEDRA Clinical Research, LLC|
|San Antonio, Texas, United States, 78217|