Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)

Overview

This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.

Full Title of Study: “An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence After Administration of a Losartan 100-mg/Hydrochlorothiazide 12.5-mg Combination Tablet and the Coadministration of a Currently Marketed COZAAR™ 100-mg Tablet and MICROZIDE™ 12.5 mg Capsule in Healthy Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2004

Interventions

  • Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)
    • Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.
  • Drug: losartan potassium
    • Single dose losartan 100 mg tablet in one of two treatment periods.
  • Drug: hydrochlorothiazide (HCTZ)
    • Single dose HCTZ 12.5 mg capsule in one of two treatment periods.

Arms, Groups and Cohorts

  • Active Comparator: losartan /HCTZ combination tablet
    • single dose losartan 100 mg/HCTZ 12.5 mg combination tablet
  • Active Comparator: losartan tablet + HCTZ capsule
    • Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule

Clinical Trial Outcome Measures

Primary Measures

  • Area Under the Curve (AUC(0 to Infinity)) of Losartan
    • Time Frame: 0 to 36 Hours Post Dose
  • Peak Plasma Concentration (Cmax) for Losartan
    • Time Frame: 36 Hours Post Dose
    • Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.
  • Area Under the Curve (AUC(0 to Infinity)) of HCTZ
    • Time Frame: 0 to 30 Hours Post Dose
    • Plasma Area Under the Curve, a measure of drug exposure following dosing
  • Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ
    • Time Frame: 30 Hours Post Dose
    • Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing

Participating in This Clinical Trial

Inclusion Criteria

  • Subject is a healthy male or female between the ages of 18 and 45 years of age – Subject does not smoke Exclusion Criteria:

  • Subject has a history of any illness that might pose additional risk to participation or confound the results of the study – Subject has a history of hepatitis B or C or significant drug allergies

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Organon and Co
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme LLC

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