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MK0524B Bioequivalence Study (0524B-070)

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ClinicalTrials.gov Identifier: NCT00943124
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : January 6, 2010
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE July 21, 2009
First Posted Date  ICMJE July 22, 2009
Results First Submitted Date  ICMJE October 9, 2009
Results First Posted Date  ICMJE January 6, 2010
Last Update Posted Date June 19, 2015
Study Start Date  ICMJE July 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2010)
  • Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid [ Time Frame: Through 48 Hours Post Dose ]
    Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin
  • Peak Plasma Concentration (Cmax) of Simvastatin Acid [ Time Frame: 48 Hours Post Dose ]
    Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin
  • Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin [ Time Frame: Through 48 Hours Post Dose ]
    Plasma Area Under the Curve of simvastatin
  • Peak Plasma Concentration (Cmax) of Simvastatin [ Time Frame: 48 Hours Post Dose ]
  • Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant [ Time Frame: 48 Hours Post Dose ]
    Plasma Area Under the Curve of Laropiprant
  • Peak Plasma Concentration (Cmax) of Laropiprant [ Time Frame: 48 Hours Post Dose ]
  • Peak Plasma Concentration (Cmax) of Nicotinuric Acid [ Time Frame: 24 Hours Post Dose ]
    Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin
  • Total Urinary Excretion of Niacin and Its Metabolites [ Time Frame: 96 Hours Post Dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2009)
  • Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid [ Time Frame: Through 48 Hours Post Dose ]
  • Peak Plasma Concentration (Cmax) of Simvastatin [ Time Frame: Through 48 Hours Post Dose ]
  • Area Under the Curve (AUC(0 to 48hr)) for Simvastatin [ Time Frame: Through 48 Hours Post Dose ]
  • Area Under the Curve (AUC(0 to 48hr)) for Laropiprant [ Time Frame: Through 48 Hours Post Dose ]
  • Peak Plasma Concentration (Cmax) of Laropiprant [ Time Frame: Through 48 Hours Post Dose ]
  • Peak Plasma Concentration (Cmax) of Nicotinuric Acid [ Time Frame: Through 48 Hours Post Dose ]
  • Total Urinary Excretion of Niacin and Niacin Metabolites [ Time Frame: Through 96 Hours Post Dose ]
Change History Complete list of historical versions of study NCT00943124 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 MK0524B Bioequivalence Study (0524B-070)
Official Title  ICMJE An Open-Label, Definitive Bioequivalence Study to Compare the Pharmacokinetics of the Simvastatin, Nicotinic Acid, and MK0524 (Laropiprant) Components of a Formulation of MK0524B With That of Zocor™ and MK0524A Tablets
Brief Summary

This study will evaluate:

  1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple combination tablet MK0524B.
  2. the bioequivalence of laropiprant and ER niacin when administered as the triple combination tablet MK0524B or as the double combination tablet MK0524A given together with simvastatin.
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 Dyslipidemia
Intervention  ICMJE
  • Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin)
    Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.
    Other Name: MK0524B
  • Drug: MK0524A (ER niacin + laropiprant)
    Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.
    Other Name: MK0524A
  • Drug: Simvastatin
    Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.
    Other Name: Zocor™
Study Arms  ICMJE
  • Experimental: MK0524B then Simvastatin + MK0524A

    Period 1: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg).

    Period 2: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets.

    Interventions:
    • Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin)
    • Drug: MK0524A (ER niacin + laropiprant)
    • Drug: Simvastatin
  • Experimental: Simvastatin + MK0524A then MK0524B

    Period 1: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets.

    Period 2: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg).

    Interventions:
    • Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin)
    • Drug: MK0524A (ER niacin + laropiprant)
    • Drug: Simvastatin
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: July 21, 2009)
220
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is in good health
  • Subject is a nonsmoker
  • Subject is willing to follow the study guidelines

Exclusion Criteria:

  • Subject has or has a history of any illness that might confound the results of the study or make participation in the study unsafe for the subject
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older 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 NCT00943124
Other Study ID Numbers  ICMJE 0524B-070
MK0524B-070
2009_612
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 May 2015

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