NCT00649597

Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Benazepril HCl and Hydrochlorothiazide Tablets (20 mg/25 mg; Mylan) to Lotensin HCT® Tablets (20 mg/25 mg; Novartis) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (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 benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg	20/25mg, single dose fasting
DRUG	Lotensin HCT® Tablets 20 mg/25 mg	20/25mg, single dose fasting

Timeline

• Start date: 2002-11-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States