MK0524A Bioequivalence Study (0524A-059)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00944645
First received: July 21, 2009
Last updated: May 7, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00944645     History of Changes
Other Study ID Numbers: 0524A-059, MK0524A-059, 2009_613
Study First Received: July 21, 2009
Results First Received: October 20, 2009
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2014