NCT00834977

Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions

Randomized, 2-way, Crossover, Bioequivalence Study of Amlodipine-Benazepril 10mg-20mg Capsules and Lotrel® Administered as 1 x 10 Mg-20 mg Capsule in Healthy Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the rate and extent of absorption of amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered as 1 x 10 mg capsule under fasting conditions.

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Amlodipine-benazepril 10 mg-20 mg capsules	1 x 10-20 mg
DRUG	Lotrel® 10 mg-20 mg capsule	1 x 10-20 mg

Timeline

• Start date: 2004-04-01
• Primary completion: 2004-05-01
• Completion: 2004-05-01
• First posted: 2009-02-03
• Last updated: 2024-09-19
• Results posted: 2009-08-18

Locations

2 sites across 1 country: Canada