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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.
August 4, 2009
August 6, 2009
May 13, 2010
July 16, 2010
January 22, 2016
April 2004
May 2004   (Final data collection date for primary outcome measure)
  • 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
  • Area under the curve (AUC(0 to infinity)) of losartan following single dose administration of losartan/HCTZ or losartan and HCTZ [ Time Frame: Through 36 hours postdose ]
  • Peak plasma concentration (Cmax) of losartan following single dose administration of losartan/HCTZ or losartan and HCTZ [ Time Frame: Through 36 hours postdose ]
  • Area under the curve (AUC(0 to infinity)) of HCTZ following single dose administration of losartan/HCTZ or losartan and HCTZ [ Time Frame: Through 30 hours postdose ]
  • Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ [ Time Frame: Through 30 hours postdose ]
Complete list of historical versions of study NCT00953680 on ClinicalTrials.gov Archive Site
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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
This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension
  • 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.
    Other Name: COZAAR™
  • Drug: hydrochlorothiazide (HCTZ)
    Single dose HCTZ 12.5 mg capsule in one of two treatment periods.
    Other Name: MICROZIDE™
  • Active Comparator: losartan /HCTZ combination tablet
    single dose losartan 100 mg/HCTZ 12.5 mg combination tablet
    Intervention: Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)
  • Active Comparator: losartan tablet + HCTZ capsule
    Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
    Interventions:
    • Drug: losartan potassium
    • Drug: hydrochlorothiazide (HCTZ)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
July 2004
May 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00953680
0954A-306
2009_628
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Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP