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Trial record 68 of 1373 for:    Area Under Curve AND tablet

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

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ClinicalTrials.gov Identifier: NCT00953680
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : July 16, 2010
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE August 4, 2009
First Posted Date  ICMJE August 6, 2009
Results First Submitted Date  ICMJE May 13, 2010
Results First Posted Date  ICMJE July 16, 2010
Last Update Posted Date January 22, 2016
Study Start Date  ICMJE April 2004
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2010)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2009)
  • 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 ]
Change History Complete list of historical versions of study NCT00953680 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)
Official Title  ICMJE 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
Brief Summary This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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™
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2009)
77
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2004
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00953680
Other Study ID Numbers  ICMJE 0954A-306
2009_628
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date January 2016

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