NCT01476176已完成1 期
A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine
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
- 30
- 试验地点
- 1
- 主要终点
- PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence
研究概览
简要总结
This PK study is designed to show bioequivalence between the study treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer
排除标准
- 未提供
研究组 & 干预措施
Experimental paracetamol formulation
Experimental
experimental formulation
干预措施: Experimental paracetamol (Drug)
paracetamol marketed formulation
Active Comparator
Paracetamol marketed formulation
干预措施: Paracetamol marketed formulation (Drug)
结局指标
主要结局
PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence
时间窗: 10 hours
次要结局
- PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)(10 hours)
研究者
研究点 (1)
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