NCT01476215已完成1 期
A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions
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
- 18
- 试验地点
- 1
- 主要终点
- Time to plasma level above therapeutic level
研究概览
简要总结
This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer
- •Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive
排除标准
- 未提供
研究组 & 干预措施
Fast dissolution suspension
Experimental
干预措施: Paracetamol fast dissolution suspension (Drug)
Medium dissolution suspension
Experimental
干预措施: Paracetamol medium dissolution suspension (Drug)
Slow dissolution suspension
Experimental
干预措施: Paracetamol slow dissolution suspension (Drug)
Marketed suspension
Active Comparator
干预措施: Paracetamol (Drug)
结局指标
主要结局
Time to plasma level above therapeutic level
时间窗: baseline to 8 hours
次要结局
- General PK parameters (e.g. AUC, Tmax, Cmax)(baseline to 8 hours)
研究者
研究点 (1)
Loading locations...
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