NCT01381640撤回1 期
A Single Dose Pharmacoscintigraphic Study Investigating the Differences in Gastrointestinal Behavior and Paracetamol Absorption Between Sustained Release Formula and Standard Release Formula
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition
研究概览
简要总结
This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects who are in good general health
- •Have not exceeded the limits of total radiation exposure (5mSv) allowed in any 12 month period
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 formulation (Drug)
Marketed paracetamol
Active Comparator
Marketed formulation
干预措施: Marketed paracetamol (Drug)
结局指标
主要结局
Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition
时间窗: Baseline to 12 hours post dosing
次要结局
- To assess the gastrointestinal transit by qualitative scintigraphic analysis(Baseline to 12 hours post dosing)
研究者
研究点 (2)
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