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 Non-fasting (Fed) Conditions

NCT01155908 Phase 1 COMPLETED

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 non-fasting (fed) conditions.

Details

Lead sponsor	Dr. Reddy's Laboratories Limited
Phase	Phase 1
Status	COMPLETED
Enrolment	48
Start date	2005-04
Completion	2005-05

Conditions

• Healthy

Interventions

• Amlodipine Besylate / Benazepril Hydrochloride

Primary outcomes

• Bioavailability based on Cmax and AUC parameters — 2 Months