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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:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00953680
First received: August 4, 2009
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Area Under the Curve (AUC(0 to Infinity)) of Losartan [ Time Frame: 0 to 36 Hours Post Dose ] [ Designated as safety issue: No ]
  • Peak Plasma Concentration (Cmax) for Losartan [ Time Frame: 36 Hours Post Dose ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953680

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00953680     History of Changes
Other Study ID Numbers: 2009_628, MK0954A-306
Study First Received: August 4, 2009
Results First Received: May 13, 2010
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013