NCT00649402

Fed Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg

Single-Dose Food 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan 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 10 mg/20 mg) dose administered under fed conditions.

Conditions

• Healhty

Interventions

Type	Name	Description
DRUG	Amlodipine and Benazepril HCl Capsules 10 mg/20 mg	10/120mg, single dose fed
DRUG	Lotrel® Capsules 10 mg/20 mg	10/20mg, single dose fed

Timeline

• Start date: 2004-05-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States