Healthy 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
- Objective:
- 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.
- Study Design:
- 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.
n/a
N/A
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