* 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.
Study Type
INTERVENTIONAL
10 mg tablets (Torrent Pharmaceuticals, India)
10 mg dose (Pfizer, USA)
CEDRA Clinical Research, LLC
San Antonio, Texas, United States
Bioequivalence
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