MK0524B Bioequivalence Study (0524B-070)
Phase 1
Completed
- Conditions
- Dyslipidemia
- Interventions
- Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin)Drug: MK0524A (ER niacin + laropiprant)
- Registration Number
- NCT00943124
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description MK0524B then Simvastatin + MK0524A MK0524B (ER niacin (+) laropiprant (+) simvastatin) 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. MK0524B then Simvastatin + MK0524A MK0524A (ER niacin + laropiprant) 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. Simvastatin + MK0524A then MK0524B MK0524B (ER niacin (+) laropiprant (+) simvastatin) 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). Simvastatin + MK0524A then MK0524B MK0524A (ER niacin + laropiprant) 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). MK0524B then Simvastatin + MK0524A Simvastatin 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. Simvastatin + MK0524A then MK0524B Simvastatin 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).
- Primary Outcome Measures
Name Time Method Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin Through 48 Hours Post Dose Plasma Area Under the Curve of simvastatin
Peak Plasma Concentration (Cmax) of Simvastatin 48 Hours Post Dose Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant 48 Hours Post Dose Plasma Area Under the Curve of Laropiprant
Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid Through 48 Hours Post Dose Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin
Peak Plasma Concentration (Cmax) of Simvastatin Acid 48 Hours Post Dose Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin
Peak Plasma Concentration (Cmax) of Laropiprant 48 Hours Post Dose Peak Plasma Concentration (Cmax) of Nicotinuric Acid 24 Hours Post Dose Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin
Total Urinary Excretion of Niacin and Its Metabolites 96 Hours Post Dose
- Secondary Outcome Measures
Name Time Method