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

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: losartan potassium (+) hydrochlorothiazide (HCTZ); Drug: losartan potassium; Drug: hydrochlorothiazide (HCTZ)

• Registration Number: NCT00953680
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2004-05
• Study Completion: 2004-07
• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Results First Submitted: 2010-05-13
• Results First Submitted QC: 2010-06-17
• Results First Posted: 2010-07-16
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
losartan tablet + HCTZ capsule	hydrochlorothiazide (HCTZ)	Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
losartan /HCTZ combination tablet	losartan potassium (+) hydrochlorothiazide (HCTZ)	single dose losartan 100 mg/HCTZ 12.5 mg combination tablet
losartan tablet + HCTZ capsule	losartan potassium	Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC(0 to Infinity)) of Losartan	0 to 36 Hours Post Dose
Peak Plasma Concentration (Cmax) for Losartan	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	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	30 Hours Post Dose	Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing