MK0524A Bioequivalence Study

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00944645
First received: July 21, 2009
Last updated: April 21, 2010
Last verified: April 2010
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measure of extent of absorption of laropiprant

  • Maximum Concentration (Cmax) of Laropiprant [ Time Frame: Predose and up to 48 hours postdose ] [ Designated as safety issue: No ]
    Measure of rate of absorption of laropiprant


Enrollment: 188
Study Start Date: October 2006
Study Completion Date: March 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944645

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00944645     History of Changes
Other Study ID Numbers: 2009_613, MK0524A-059
Study First Received: July 21, 2009
Results First Received: October 20, 2009
Last Updated: April 21, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014