MK0524B Bioequivalence Study (0524B-070)

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943124
• Other study ID #: 0524B-070
• Secondary ID: MK0524B-0702009_
• Status: Completed
• Phase: Phase 1
• First received: July 21, 2009
• Last updated: May 22, 2015
• Start date: July 2007
• Est. completion date: August 2007

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

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.
• MK0524A (ER niacin + laropiprant)
Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.
• Simvastatin
Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid	Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin	Through 48 Hours Post Dose	No
Primary	Peak Plasma Concentration (Cmax) of Simvastatin Acid	Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin	48 Hours Post Dose	No
Primary	Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin	Plasma Area Under the Curve of simvastatin	Through 48 Hours Post Dose	No
Primary	Peak Plasma Concentration (Cmax) of Simvastatin		48 Hours Post Dose	No
Primary	Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant	Plasma Area Under the Curve of Laropiprant	48 Hours Post Dose	No
Primary	Peak Plasma Concentration (Cmax) of Laropiprant		48 Hours Post Dose	No
Primary	Peak Plasma Concentration (Cmax) of Nicotinuric Acid	Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin	24 Hours Post Dose	No
Primary	Total Urinary Excretion of Niacin and Its Metabolites		96 Hours Post Dose	No