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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 220
- 主要终点
- Total Urinary Excretion of Niacin and Its Metabolites
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is in good health
- •Subject is a nonsmoker
- •Subject is willing to follow the study guidelines
排除标准
- •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
研究组 & 干预措施
MK0524B then Simvastatin + MK0524A
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.
干预措施: MK0524B (ER niacin (+) laropiprant (+) simvastatin) (Drug)
MK0524B then Simvastatin + MK0524A
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.
干预措施: MK0524A (ER niacin + laropiprant) (Drug)
MK0524B then Simvastatin + MK0524A
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.
干预措施: Simvastatin (Drug)
Simvastatin + MK0524A then MK0524B
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).
干预措施: MK0524B (ER niacin (+) laropiprant (+) simvastatin) (Drug)
Simvastatin + MK0524A then MK0524B
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).
干预措施: MK0524A (ER niacin + laropiprant) (Drug)
Simvastatin + MK0524A then MK0524B
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).
干预措施: Simvastatin (Drug)
结局指标
主要结局
Total Urinary Excretion of Niacin and Its Metabolites
时间窗: 96 Hours Post Dose
Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin
时间窗: Through 48 Hours Post Dose
Plasma Area Under the Curve of simvastatin
Peak Plasma Concentration (Cmax) of Simvastatin
时间窗: 48 Hours Post Dose
Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant
时间窗: 48 Hours Post Dose
Plasma Area Under the Curve of Laropiprant
Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid
时间窗: 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
时间窗: 48 Hours Post Dose
Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin
Peak Plasma Concentration (Cmax) of Laropiprant
时间窗: 48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Nicotinuric Acid
时间窗: 24 Hours Post Dose
Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin
次要结局
未报告次要终点