MK0524B Bioequivalence Study (0524B-070)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00943124
First received: July 21, 2009
Last updated: May 7, 2014
Last verified: May 2014
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Plasma Area Under the Curve of simvastatin

  • Peak Plasma Concentration (Cmax) of Simvastatin [ Time Frame: 48 Hours Post Dose ] [ Designated as safety issue: No ]
  • Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant [ Time Frame: 48 Hours Post Dose ] [ Designated as safety issue: No ]
    Plasma Area Under the Curve of Laropiprant

  • Peak Plasma Concentration (Cmax) of Laropiprant [ Time Frame: 48 Hours Post Dose ] [ Designated as safety issue: No ]
  • Peak Plasma Concentration (Cmax) of Nicotinuric Acid [ Time Frame: 24 Hours Post Dose ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: July 2007
Study Completion Date: October 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

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 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
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: NCT00943124

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: NCT00943124     History of Changes
Other Study ID Numbers: 0524B-070, MK0524B-070, 2009_612
Study First Received: July 21, 2009
Results First Received: October 9, 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
Simvastatin
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
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014