NCT01164800

Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fed Conditions

An Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover Comparative Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited and Mavik® 4 mg Tablets of Abbott Laboratories, in Healthy, Adult, Human Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Trandolapril	Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited
DRUG	Mavik	Mavik® 4 mg Tablets of Abbott Laboratories, USA.

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-04-01
• Completion: 2006-05-01
• First posted: 2010-07-19
• Last updated: 2010-07-19

Locations

1 site across 1 country: India