An Open Label, Randomized, 2-Period, Crossover Study to Establish the Definitive Bioequivalence of Niacin and MK0524 of 2 Sources of MK0524A Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 188
- 主要终点
- Maximum Plasma Concentration (Cmax) of Nicotinuric Acid
研究概览
简要总结
This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.
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 willing to follow all study guidelines
排除标准
- •Subject has or has a history of any disease or condition that might confound the results of the study or make participation unsafe
研究组 & 干预措施
A
MK0524A Source 1 (Phase III manufacturing site)
干预措施: niacin (+) laropiprant (Source 1) (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Nicotinuric Acid
时间窗: Predose and up to 24 hours postdose
Measure of rate of absorption of ER niacin
Total Amount of Urinary Excretion of Niacin and Its Metabolites
时间窗: Predose and up to 96 hours postdose
Measure of extent of absorption of ER niacin
Area Under Curve (AUC 0-infinity) of Laropiprant
时间窗: Predose and up to 48 hours postdose
Measure of extent of absorption of laropiprant
Maximum Concentration (Cmax) of Laropiprant
时间窗: Predose and up to 48 hours postdose
Measure of rate of absorption of laropiprant
次要结局
未报告次要终点