Bioequivalency Study of Losartan Potassium 100 mg Tablet Under Fed Conditions
Not Applicable
Completed
- Conditions
- Hypertension
- Registration Number
- NCT01216878
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet under fasted conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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 losartan potassium or any comparable or similar product.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method bioequivalence determined by statistical comparison Cmax 15 days
- 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 molecular mechanisms of losartan potassium influence angiotensin II receptor blockade in hypertension?
How does losartan potassium compare to other ARBs in managing blood pressure under fed conditions?
What biomarkers correlate with losartan potassium efficacy in hypertensive patients with renal impairment?
What adverse events are associated with losartan potassium 100 mg tablets in clinical trials?
How do losartan potassium formulations compare to valsartan in bioavailability and patient outcomes?
Trial Locations
- Locations (1)
BioKinetic Clinical Applications, Inc.
🇺🇸Springfield, Missouri, United States
BioKinetic Clinical Applications, Inc.🇺🇸Springfield, Missouri, United States