The objective of this study was to prove the bioequivalence of losartan potassium/hydrochlorothiazide 100/25 mg tablet under fed conditions.
Full Title of Study: “A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide Tablets 100 mg/25 mg Under Fed Conditions”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 2005
- Drug: losartan potassium hydrochlorothiazide
- 100 mg / 25 mg tablet
Clinical Trial Outcome Measures
- Bioequivalence determined by statistical comparison Cmax
- Time Frame: 25 days
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Roxane Laboratories
- Provider of Information About this Clinical Study
- Elizabeth Ernst, Roxane Laboratories, Inc.
- Overall Official(s)
- Daniel V Freeland, D.O., Principal Investigator, CEDRA Clinical Research, LLC
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