Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg /25 mg Tablet Under Fed Conditions
Not Applicable
Completed
- Conditions
- Hypertension
- Registration Number
- NCT01102465
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
The objective of this study was to prove the bioequivalence of losartan potassium/hydrochlorothiazide 100/25 mg tablet under fed conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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 hydrochlorothiazide 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 25 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 are the molecular mechanisms of losartan potassium and hydrochlorothiazide in hypertension management?
How does the losartan/hydrochlorothiazide combination compare to other antihypertensive drug classes in clinical efficacy?
Are there specific biomarkers that predict patient response to losartan potassium/hydrochlorothiazide therapy in essential hypertension?
What are the potential adverse events associated with losartan potassium/hydrochlorothiazide 100/25 mg tablets under fed conditions?
How do losartan potassium/hydrochlorothiazide formulations from Roxane Laboratories compare to competitor drugs in bioavailability and patient outcomes?
Trial Locations
- Locations (1)
CEDRA Clinical Research, LLC
🇺🇸Austin, Texas, United States
CEDRA Clinical Research, LLC🇺🇸Austin, Texas, United States