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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: losartan potassium (+) hydrochlorothiazide (HCTZ); Drug: losartan potassium; Drug: hydrochlorothiazide (HCTZ)

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: losartan /HCTZ combination tablet; single dose losartan 100 mg/HCTZ 12.5 mg combination tablet	Drug: losartan potassium (+) hydrochlorothiazide (HCTZ); Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.
Active Comparator: losartan tablet + HCTZ capsule; Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule	Drug: losartan potassium; Single dose losartan 100 mg tablet in one of two treatment periods.; Other Names: COZAAR™; Drug: hydrochlorothiazide (HCTZ); Single dose HCTZ 12.5 mg capsule in one of two treatment periods.; Other Names: MICROZIDE™

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): May 1, 2004
• Study Completion (Actual): July 1, 2004

Study Registration Dates

• First Submitted: August 4, 2009
• First Submitted That Met QC Criteria: August 4, 2009
• First Posted (Estimate): August 6, 2009

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Losartan; Hydrochlorothiazide
• Other Study ID Numbers: 0954A-306; 2009_628