NCT00836537

Benazepril HCl 40 mg Tablets, Fed

A Relative Bioavailability Study of 40 mg Benazepril Hydrochloride Tablets Under Non-Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 40 mg Benazepril Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 40 mg LOTENSIN® Tablets by Novartis Pharmaceuticals following a single oral dose (1 x 40 mg) in healthy adult volunteers under non-fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Benazepril HCl 40 mg Tablets	1 x 40 mg, single-dose fed
DRUG	Lotensin® 40 mg Tablets	1 x 40 mg, single-dose fed

Timeline

• Start date: 2001-03-01
• Primary completion: 2001-03-01
• Completion: 2001-03-01
• First posted: 2009-02-04
• Last updated: 2023-05-12

Locations

1 site across 1 country: United States