A Relative Bioavailability Study of Moexipril HCl 15 mg Tablets Under Fasting Conditions
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00992862
- Lead Sponsor
- Paddock Laboratories, Inc.
- Brief Summary
The purpose of this study is to compare the relative bioavailability of Moexipril HCl 15mg tablets (by Paddock Laboratories, Inc.) with that of Univasc® 15mg tablets (by Schwarz Pharma) following a single oral dose (1 x 15mg tablet) in healthy, adult subjects under fasting conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening
Exclusion Criteria
- Positive test results for HIV or Hepatitis B or C
- History of allergy or sensitivity to Moexipril HCl or related drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Moexipril HCl 15mg Tablets Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc. - Univasc® 15mg Tablets Univasc® 15mg Tablets -
- Primary Outcome Measures
Name Time Method Bioequivalence according to US FDA guidelines
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novum Pharmaceutical Research Services
🇺🇸Pittsburg, Pennsylvania, United States