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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.
Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.
Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.
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
Time frame: Through 48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Simvastatin Acid
Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin
Time frame: 48 Hours Post Dose
Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin
Plasma Area Under the Curve of simvastatin
Time frame: Through 48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Simvastatin
Time frame: 48 Hours Post Dose
Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant
Plasma Area Under the Curve of Laropiprant
Time frame: 48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Laropiprant
Time frame: 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
Time frame: 24 Hours Post Dose
Total Urinary Excretion of Niacin and Its Metabolites
Time frame: 96 Hours Post Dose
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