Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg Tablet Under Fasted Conditions
Not Applicable
Completed
- Conditions
- Hypertension
- Registration Number
- NCT01102478
- 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 fasted conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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?
Which biomarkers are associated with response prediction to angiotensin II receptor blockers like losartan in hypertensive patients?
What adverse events are commonly reported with losartan potassium/hydrochlorothiazide combination therapy and how are they managed?
What are the current competitor drugs to losartan potassium/hydrochlorothiazide in the treatment of essential hypertension?
Trial Locations
- Locations (1)
CEDRA Clinical Research, LLC
🇺🇸Austin, Texas, United States
CEDRA Clinical Research, LLC🇺🇸Austin, Texas, United States