NCT00836576

Benazepril HCl 40 mg Tablets, Fasting

A Randomized, Two-way Crossover, Single-dose, Open-label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Benazepril HCl (40 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Lotensin®, Novartis Pharmaceuticals Corporation) in 40 Fasted, Healthy, Adult Subjects

• 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

The objective of this randomized, single-dose, two-way crossover evaluation is to compare the oral bioavailability of a test benazepril HCl formulation (TEVA Pharmaceutical Industries Ltd.) to an equivalent oral dose of the commercially available benazepril HCl (Lotensin®, Novartis Pharmaceuticals Corporation) in a test population of 40 adults under 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 fasting
DRUG	Lotensin® 40 mg Tablets	1 x 40 mg, single-dose fasting

Timeline

• Start date: 2001-02-01
• Primary completion: 2001-03-01
• Completion: 2001-03-01
• First posted: 2009-02-04
• Last updated: 2024-08-19

Locations

1 site across 1 country: United States