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MK0524B Bioequivalence Study (0524B-070)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00943124
First Posted: July 22, 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:

  1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple combination tablet MK0524B.
  2. the bioequivalence of laropiprant and ER niacin when administered as the triple combination tablet MK0524B or as the double combination tablet MK0524A given together with simvastatin.

Condition Intervention Phase
Dyslipidemia Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin) Drug: MK0524A (ER niacin + laropiprant) Drug: Simvastatin 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, Definitive Bioequivalence Study to Compare the Pharmacokinetics of the Simvastatin, Nicotinic Acid, and MK0524 (Laropiprant) Components of a Formulation of MK0524B With That of Zocor™ and MK0524A Tablets

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid [ Time Frame: Through 48 Hours Post Dose ]
    Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin

  • Peak Plasma Concentration (Cmax) of Simvastatin Acid [ Time Frame: 48 Hours Post Dose ]
    Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin

  • Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin [ Time Frame: Through 48 Hours Post Dose ]
    Plasma Area Under the Curve of simvastatin

  • Peak Plasma Concentration (Cmax) of Simvastatin [ Time Frame: 48 Hours Post Dose ]
  • Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant [ Time Frame: 48 Hours Post Dose ]
    Plasma Area Under the Curve of Laropiprant

  • Peak Plasma Concentration (Cmax) of Laropiprant [ Time Frame: 48 Hours Post Dose ]
  • Peak Plasma Concentration (Cmax) of Nicotinuric Acid [ Time Frame: 24 Hours Post Dose ]
    Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin

  • Total Urinary Excretion of Niacin and Its Metabolites [ Time Frame: 96 Hours Post Dose ]

Enrollment: 220
Study Start Date: July 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK0524B then Simvastatin + MK0524A

Period 1: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg).

Period 2: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets.

Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin)
Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.
Other Name: MK0524B
Drug: MK0524A (ER niacin + laropiprant)
Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.
Other Name: MK0524A
Drug: Simvastatin
Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.
Other Name: Zocor™
Experimental: Simvastatin + MK0524A then MK0524B

Period 1: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets.

Period 2: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg).

Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin)
Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.
Other Name: MK0524B
Drug: MK0524A (ER niacin + laropiprant)
Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.
Other Name: MK0524A
Drug: Simvastatin
Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.
Other Name: Zocor™

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 a nonsmoker
  • Subject is willing to follow the study guidelines

Exclusion Criteria:

  • Subject has or has a history of any illness that might confound the results of the study or make participation in the study unsafe for the subject
  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): NCT00943124


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: NCT00943124     History of Changes
Other Study ID Numbers: 0524B-070
MK0524B-070
2009_612
First Submitted: July 21, 2009
First Posted: July 22, 2009
Results First Submitted: October 9, 2009
Results First Posted: January 6, 2010
Last Update Posted: June 19, 2015
Last Verified: May 2015

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