A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide in Healthy Adult Volunteers Under Fasting Conditions
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Uniretic® 15mg/25mg Tablets
- Registration Number
- NCT00990301
- Lead Sponsor
- Paddock Laboratories, Inc.
- Brief Summary
The purpose of this study was to evaluate the relative bioavailability of Paddock Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets with a reference formulation Uniretic®(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets, under fasting conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening
Exclusion Criteria
- Positive test results for HIV or Hepatitis B or C
- History of allergy or sensitivity to Moexipril, Hydrochlorothiazide or related drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Moexipril HCl/ Hydrochlorothiazide 15mg/25mg Tablets Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc. - Uniretic® 15mg/25mg Tablets Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc. - Uniretic® 15mg/25mg Tablets Uniretic® 15mg/25mg Tablets -
- Primary Outcome Measures
Name Time Method Bioequivalence specified outcomes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novum Pharmaceutical Research Services
🇺🇸Pittsburg, Pennsylvania, United States
Novum Pharmaceutical Research Services🇺🇸Pittsburg, Pennsylvania, United States