Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg Tablet Under Fasted Conditions

Overview

The objective of this study was to prove the bioequivalence of Losartan Potassium/Hydrochlorothiazide 100/25 mg tablet under fasted 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 Fasting Conditions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2005

Interventions

  • Drug: losartan potassium / hydrochlorothiazide
    • 100 mg / 25 mg tablet

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence determined by statistical comparison Cmax
    • Time Frame: 25 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • 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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