Single-Dose Fasting In Vivo Bioequivalence Study of Amlodipine and Benazepril HCl Capsules (10 mg/20 mg; Mylan) to Lotrel® Capsules (10 mg/20 mg; Novartis) in Healthy Volunteers

NCT00649519 Phase 1 COMPLETED

The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a single, oral 10 mg/20 mg (1 x 10mg/20mg) dose administered under fasting conditions.

Details

Lead sponsor	Mylan Pharmaceuticals Inc
Phase	Phase 1
Status	COMPLETED
Enrolment	54
Start date	2004-05
Completion	2004-05

Conditions

• Healthy

Interventions

• Amlodipine and Benazepril HCl Capsules 10 mg/20 mg
• Lotrel® Capsules 10 mg/20 mg

Primary outcomes

• Bioequivalence — within 30 days

Countries

United States