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

NCT00953680 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2022-02-09

Study results available
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Summary

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

Conditions

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.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2004-05-31
Completion
2004-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00953680 on ClinicalTrials.gov