Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions
Not Applicable
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00702260
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under fed conditions.
- Detailed Description
Not available
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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of Ramipril's action in hypertension management under fed conditions?
How does Ramipril compare to other ACE inhibitors in bioavailability when administered with food?
Are there specific biomarkers that influence Ramipril's efficacy in hypertensive patients post-meal?
What adverse events are associated with Ramipril 10 mg in fed versus fasted states and how are they managed?
What is the therapeutic relevance of Ramipril's bioequivalence in relation to competitor drugs for hypertension?
Trial Locations
- Locations (1)
CEDRA Clinical Research, LLC
🇺🇸Austin, Texas, United States
CEDRA Clinical Research, LLC🇺🇸Austin, Texas, United States