NCT00829530

Ramipril 10 mg Capsule in Healthy Subjects Under Fed Conditions

Randomized, 2-Way Crossover, Bioequivalence Study of Ramipril 10 mg Capsule and Altace® Administered as 1 x 10 mg Capsule in Healthy Subjects Under Fed 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

The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg capsule (test) versus Altace® (reference), administered as 1 x 10 mg capsule under fed conditions.

Detailed description

Detailed Description Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ramipril 10 mg capsule	1 x 10 mg
DRUG	Altace® 10 mg capsule	1 x 10 mg

Timeline

• Start date: 2004-08-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2009-01-27
• Last updated: 2024-08-19
• Results posted: 2009-08-18

Locations

2 sites across 1 country: Canada