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The purpose of this study is
- To compare the single oral dose bioavailability of test product, Trandolapril 4 mg Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult, human subjects, under fed conditions to assess bioequivalence.
- To monitor adverse events and ensure safety of subjects.
An open label, randomised, two-treatment, two-sequence, two-period, two-way cross-over,single-dose bioequivalence study of Trandolapril4 mg Tablets manufactured by Dr. Reddy's Laboratories Ltd., Generics, India comparing with the Mavik® 4 mg Tablets (containing trandolapril 4 mg) manufactured by Abbott Laboratories, North Chicago, IL 60064, US; in healthy, adult, human subjects under fed conditions with a wash out period of 30 days between two periods.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Wellquest Clinical Research
Dr. Reddy's Laboratories Limited
Published on BioPortfolio: 2014-08-27T04:00:18-0400
The objective of this study is to compare the rate and extent of absorption of trandolapril from a test formulation of Trandolapril 4 mg Tablets versus the reference Mavik® 4 mg Tablets u...
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