Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT00702091
• Lead Sponsor: Roxane Laboratories

Brief Summary

The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria

• Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Ramipril or any comparable or similar product.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bioequivalence	Baseline, two-period, 7 day washout

Trial Locations

Locations (1)

CEDRA Clinical Research, LLC; 🇺🇸 Austin, Texas, United States