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MK0524B Bioequivalence Study (0524B-070)

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK0524B (ER niacin (+) laropiprant (+) simvastatin)
MK0524A (ER niacin + laropiprant)
Simvastatin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    MK0524B then Simvastatin + MK0524A

    Simvastatin + MK0524A then MK0524B

    Arm Description

    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.

    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).

    Outcomes

    Primary Outcome Measures

    Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid
    Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin
    Peak Plasma Concentration (Cmax) of Simvastatin Acid
    Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin
    Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin
    Plasma Area Under the Curve of simvastatin
    Peak Plasma Concentration (Cmax) of Simvastatin
    Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant
    Plasma Area Under the Curve of Laropiprant
    Peak Plasma Concentration (Cmax) of Laropiprant
    Peak Plasma Concentration (Cmax) of Nicotinuric Acid
    Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin
    Total Urinary Excretion of Niacin and Its Metabolites

    Secondary Outcome Measures

    Full Information

    First Posted
    July 21, 2009
    Last Updated
    May 22, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00943124
    Brief Title
    MK0524B Bioequivalence Study (0524B-070)
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    This study will evaluate: 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    220 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK0524B then Simvastatin + MK0524A
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Simvastatin + MK0524A then MK0524B
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    MK0524B (ER niacin (+) laropiprant (+) simvastatin)
    Other Intervention Name(s)
    MK0524B
    Intervention Description
    Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.
    Intervention Type
    Drug
    Intervention Name(s)
    MK0524A (ER niacin + laropiprant)
    Other Intervention Name(s)
    MK0524A
    Intervention Description
    Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.
    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatin
    Other Intervention Name(s)
    Zocor™
    Intervention Description
    Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.
    Primary Outcome Measure Information:
    Title
    Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid
    Description
    Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin
    Time Frame
    Through 48 Hours Post Dose
    Title
    Peak Plasma Concentration (Cmax) of Simvastatin Acid
    Description
    Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin
    Time Frame
    48 Hours Post Dose
    Title
    Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin
    Description
    Plasma Area Under the Curve of simvastatin
    Time Frame
    Through 48 Hours Post Dose
    Title
    Peak Plasma Concentration (Cmax) of Simvastatin
    Time Frame
    48 Hours Post Dose
    Title
    Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant
    Description
    Plasma Area Under the Curve of Laropiprant
    Time Frame
    48 Hours Post Dose
    Title
    Peak Plasma Concentration (Cmax) of Laropiprant
    Time Frame
    48 Hours Post Dose
    Title
    Peak Plasma Concentration (Cmax) of Nicotinuric Acid
    Description
    Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin
    Time Frame
    24 Hours Post Dose
    Title
    Total Urinary Excretion of Niacin and Its Metabolites
    Time Frame
    96 Hours Post Dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    MK0524B Bioequivalence Study (0524B-070)

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