Skip to main content
OpenTrials
Completed

NCT Number: NCT00943124

MK0524B Bioequivalence Study (0524B-070)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0524B (ER niacin (+) laropiprant (+) simvastatin)

Drug

Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.

Other names: MK0524B

MK0524A (ER niacin + laropiprant)

Drug

Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.

Other names: MK0524A

simvastatin

Drug

Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.

Other names: Zocor™

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Peak Plasma Concentration (Cmax) of Simvastatin

    Time frame: 48 Hours Post Dose

  5. Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant

    Time frame: 48 Hours Post Dose

    Plasma Area Under the Curve of Laropiprant

  6. Peak Plasma Concentration (Cmax) of Laropiprant

    Time frame: 48 Hours Post Dose

  7. 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

  8. Total Urinary Excretion of Niacin and Its Metabolites

    Time frame: 96 Hours Post Dose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 22, 2009
Registry last updated
Jun 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.