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MK0524A Bioequivalence Study (0524A-059)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944645
First Posted: July 23, 2009
Last Update Posted: June 19, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.

Condition Intervention Phase
Dyslipidemia Drug: niacin (+) laropiprant (Source 1) Drug: Comparator: niacin (+) laropiprant (Source 2) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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


Enrollment: 188
Study Start Date: October 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
MK0524A Source 1 (Phase III manufacturing site)
Drug: niacin (+) laropiprant (Source 1)
Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.
Active Comparator: B
MK0524A Source 2 (commercial manufacturing site)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944645


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00944645     History of Changes
Other Study ID Numbers: 0524A-059
MK0524A-059
2009_613
First Submitted: July 21, 2009
First Posted: July 23, 2009
Results First Submitted: October 20, 2009
Results First Posted: November 25, 2009
Last Update Posted: June 19, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs