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MK0524A Bioequivalence Study (0524A-059)

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
niacin (+) laropiprant (Source 1)
Comparator: niacin (+) laropiprant (Source 2)
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 willing to follow all study guidelines

Exclusion Criteria:

  • Subject has or has a history of any disease or condition that might confound the results of the study or make participation unsafe

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    A

    B

    Arm Description

    MK0524A Source 1 (Phase III manufacturing site)

    MK0524A Source 2 (commercial manufacturing site)

    Outcomes

    Primary Outcome Measures

    Maximum Plasma Concentration (Cmax) of Nicotinuric Acid
    Measure of rate of absorption of ER niacin
    Total Amount of Urinary Excretion of Niacin and Its Metabolites
    Measure of extent of absorption of ER niacin
    Area Under Curve (AUC 0-infinity) of Laropiprant
    Measure of extent of absorption of laropiprant
    Maximum Concentration (Cmax) of Laropiprant
    Measure of rate of absorption of laropiprant

    Secondary Outcome Measures

    Full Information

    First Posted
    July 21, 2009
    Last Updated
    May 25, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00944645
    Brief Title
    MK0524A Bioequivalence Study (0524A-059)
    Official Title
    An Open Label, Randomized, 2-Period, Crossover Study to Establish the Definitive Bioequivalence of Niacin and MK0524 of 2 Sources of MK0524A Tablets
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2006 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    January 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 definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.

    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
    188 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Arm Description
    MK0524A Source 1 (Phase III manufacturing site)
    Arm Title
    B
    Arm Type
    Active Comparator
    Arm Description
    MK0524A Source 2 (commercial manufacturing site)
    Intervention Type
    Drug
    Intervention Name(s)
    niacin (+) laropiprant (Source 1)
    Intervention Description
    Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: niacin (+) laropiprant (Source 2)
    Intervention Description
    Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.
    Primary Outcome Measure Information:
    Title
    Maximum Plasma Concentration (Cmax) of Nicotinuric Acid
    Description
    Measure of rate of absorption of ER niacin
    Time Frame
    Predose and up to 24 hours postdose
    Title
    Total Amount of Urinary Excretion of Niacin and Its Metabolites
    Description
    Measure of extent of absorption of ER niacin
    Time Frame
    Predose and up to 96 hours postdose
    Title
    Area Under Curve (AUC 0-infinity) of Laropiprant
    Description
    Measure of extent of absorption of laropiprant
    Time Frame
    Predose and up to 48 hours postdose
    Title
    Maximum Concentration (Cmax) of Laropiprant
    Description
    Measure of rate of absorption of laropiprant
    Time Frame
    Predose and up to 48 hours postdose

    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 willing to follow all study guidelines Exclusion Criteria: Subject has or has a history of any disease or condition that might confound the results of the study or make participation unsafe
    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

    MK0524A Bioequivalence Study (0524A-059)

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