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.
Read More
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.
Read More
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
Trial Locations
- Locations (1)
CEDRA Clinical Research, LLC
🇺🇸Austin, Texas, United States