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MK0524A Bioequivalence Study (0524A-059)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00944645
Recruitment Status : Completed
First Posted : July 23, 2009
Results First Posted : November 25, 2009
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE July 21, 2009
First Posted Date  ICMJE July 23, 2009
Results First Submitted Date  ICMJE October 20, 2009
Results First Posted Date  ICMJE November 25, 2009
Last Update Posted Date June 19, 2015
Study Start Date  ICMJE October 2006
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2009)
  • Maximum Plasma Concentration (Cmax) of Nicotinuric Acid [ Time Frame: Predose and up to 24 hours postdose ]
    Measure of rate of absorption of ER niacin
  • Total Amount of Urinary Excretion of Niacin and Its Metabolites [ Time Frame: Predose and up to 96 hours postdose ]
    Measure of extent of absorption of ER niacin
  • Area Under Curve (AUC 0-infinity) of Laropiprant [ Time Frame: Predose and up to 48 hours postdose ]
    Measure of extent of absorption of laropiprant
  • Maximum Concentration (Cmax) of Laropiprant [ Time Frame: Predose and up to 48 hours postdose ]
    Measure of rate of absorption of laropiprant
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
  • Peak plasma concentration (Cmax) of nicotinuric acid following administration of MK0524A [ Time Frame: 24 Hours post dose ]
  • Total urinary excretion of niacin and niacin metabolites following administration of MK0524A [ Time Frame: 24 Hours post dose ]
  • Plasma area under the curve (AUC(0 to infinity)) of laropiprant following administration of MK0524A [ Time Frame: 24 Hours post dose ]
  • Plasma peak concentration (Cmax) of laropiprant following administration of MK0524A [ Time Frame: 24 Hours post dose ]
Change History
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 MK0524A Bioequivalence Study (0524A-059)
Official Title  ICMJE An Open Label, Randomized, 2-Period, Crossover Study to Establish the Definitive Bioequivalence of Niacin and MK0524 of 2 Sources of MK0524A Tablets
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.
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: niacin (+) laropiprant (Source 1)
    Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.
  • Drug: Comparator: niacin (+) laropiprant (Source 2)
    Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.
Study Arms  ICMJE
  • Active Comparator: A
    MK0524A Source 1 (Phase III manufacturing site)
    Intervention: Drug: niacin (+) laropiprant (Source 1)
  • Active Comparator: B
    MK0524A Source 2 (commercial manufacturing site)
    Intervention: Drug: Comparator: niacin (+) laropiprant (Source 2)
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: October 20, 2009)
188
Original Actual Enrollment  ICMJE
 (submitted: July 22, 2009)
160
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT00944645
Other Study ID Numbers  ICMJE 0524A-059
MK0524A-059
2009_613
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date May 2015

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