To Demonstrate the Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fasting Conditions
Phase 1
Completed
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00946465
- Lead Sponsor
- Sandoz
- Brief Summary
To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under fasting conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Ramipril 10 Capsule (Sandoz) Ramipril 10 Capsule (Sandoz) 2 Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical) Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)
- Primary Outcome Measures
Name Time Method Bioequivalence based on AUC and Cmax 30 days
- Secondary Outcome Measures
Name Time Method