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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00953680
First received: August 4, 2009
Last updated: September 10, 2010
Last verified: September 2010

August 4, 2009
September 10, 2010
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 ] [ 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
  • 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 ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) of losartan following single dose administration of losartan/HCTZ or losartan and HCTZ [ Time Frame: Through 36 hours postdose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) of HCTZ following single dose administration of losartan/HCTZ or losartan and HCTZ [ Time Frame: Through 30 hours postdose ] [ Designated as safety issue: No ]
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00953680
2009_628, MK0954A-306
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2010

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