NCT00945035已完成1 期
An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of the 20% and 30% Etoricoxib (MK0663) Formulations
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Peak Plasma Concentration (Cmax) for Etoricoxib
研究概览
简要总结
This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is in good health
- •Subject agrees to follow the study guidelines
排除标准
- •Subject is a smoker
- •Subject has a history of adverse reactions caused by NSAIDs or allergies/intolerance to NSAIDs
- •Subject is in a situation or has a condition/disease which may interfere with optimal participation in the study
研究组 & 干预措施
A
Active Comparator
Etoricoxib, 20% tablet
干预措施: etoricoxib (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) for Etoricoxib
时间窗: Through 120 Hours Postdose
Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib
时间窗: Through 120 Hours Postdose
The area under the plasma concentration vs time curve.
次要结局
未报告次要终点
研究者
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