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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953680
First Posted: August 6, 2009
Last Update Posted: January 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.

Condition Intervention Phase
Hypertension Drug: losartan potassium (+) hydrochlorothiazide (HCTZ) Drug: losartan potassium Drug: hydrochlorothiazide (HCTZ) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome 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


Enrollment: 77
Study Start Date: April 2004
Study Completion Date: July 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: COZAAR™
Drug: hydrochlorothiazide (HCTZ)
Single dose HCTZ 12.5 mg capsule in one of two treatment periods.
Other Name: MICROZIDE™

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953680


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00953680     History of Changes
Other Study ID Numbers: 0954A-306
2009_628
First Submitted: August 4, 2009
First Posted: August 6, 2009
Results First Submitted: May 13, 2010
Results First Posted: July 16, 2010
Last Update Posted: January 22, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Hydrochlorothiazide
Losartan
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists