MK0524B Bioequivalence Study (0524B-070)

Study Overview
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Brief Summary
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This study will evaluate: 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. 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.

Official Title
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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

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin)
* Drug: MK0524A (ER niacin + laropiprant)
* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK0524B then Simvastatin + MK0524A<br>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)<br>* Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.<br>* Other names: MK0524B;Drug: MK0524A (ER niacin + laropiprant)<br>* Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.<br>* Other names: MK0524A;Drug: Simvastatin<br>* Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.<br>* Other names: Zocor™;|
| Experimental: Simvastatin + MK0524A then MK0524B<br>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)<br>* Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.<br>* Other names: MK0524B;Drug: MK0524A (ER niacin + laropiprant)<br>* Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.<br>* Other names: MK0524A;Drug: Simvastatin<br>* Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.<br>* Other names: Zocor™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Peak Plasma Concentration (Cmax) of Simvastatin Acid | Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin | 48 Hours Post Dose | 
| Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin | Plasma Area Under the Curve of simvastatin | Through 48 Hours Post Dose | 
| Peak Plasma Concentration (Cmax) of Simvastatin |  | 48 Hours Post Dose | 
| Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant | Plasma Area Under the Curve of Laropiprant | 48 Hours Post Dose | 
| Peak Plasma Concentration (Cmax) of Laropiprant |  | 48 Hours Post Dose | 
| 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 | 
| Total Urinary Excretion of Niacin and Its Metabolites |  | 96 Hours Post Dose |