Bioequivalency Study of Losartan Potassium 100 mg Tablet Under Fasted Conditions
Not Applicable
Completed
- Conditions
- Hypertension
- Registration Number
- NCT01216852
- 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 affect angiotensin II receptor blockade in hypertension management?
How does the bioequivalence of Roxane's Losartan 100 mg compare to standard-of-care ARB formulations under fasted conditions?
Which biomarkers correlate with Losartan Potassium pharmacokinetics in patients with essential hypertension?
What adverse events are associated with single-dose Losartan Potassium 100 mg in fasted hypertensive subjects?
How do CYP2C9 and CYP3A4 polymorphisms influence Losartan Potassium bioavailability in bioequivalence studies?
Trial Locations
- Locations (1)
Bio-Kinetic Clinical Applications, Inc.
🇺🇸Springfield, Missouri, United States
Bio-Kinetic Clinical Applications, Inc.🇺🇸Springfield, Missouri, United States