NCT01155895

Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of 10 mg Amlodipine Besylate/20 mg Benazepril Hydrochloride Capsules in Healthy Adult Male Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril hydrochloride capsules, under fasting conditions.

Detailed description

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Laboratories, Ltd. and Novartis (Lotrel®) 10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules in Healthy Adult Male Volunteers under Fasting Conditions

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Amlodipine Besylate / Benazepril Hydrochloride	10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules

Timeline

• Start date: 2004-03-01
• Primary completion: 2004-03-01
• Completion: 2004-04-01
• First posted: 2010-07-02
• Last updated: 2010-07-02