NCT00953680

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-04-01
• Primary completion: 2004-05-01
• Completion: 2004-07-01
• First posted: 2009-08-06
• Last updated: 2022-02-09
• Results posted: 2010-07-16