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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