The objective of this study was to compare the rate and extent of absorption of Ranbaxy amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one tablet dose in fed state subjects.
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on Amlodipine besylate formulations comparing Amlodipine 10mg tablets of Ranbaxy Laboratories with (Norvasc®, Pfizer Inc USA, in healthy, adult, human, subjects under fed conditions Enrolled and randomized: 40 each treatment) Drop-outs (withdrew from study): 1 Withdrawals (was dropped from study): 4 Completed: 36
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
40
SFBC Ft. Myers, Inc.
Fort Myers, Florida, United States
Bioequivalence
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