NCT01592227已完成1 期
A Pharmacokinetic Study Investigating the Rate and Extent of Absorption of Paracetamol and an Adjuvant From Two Different Paracetamol 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
- 30
- 试验地点
- 1
- 主要终点
- Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states
研究概览
简要总结
A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol 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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteers aged 18-55 years with a body mass index ranging from 19-28 kilograms per square meter who have given informed consent
排除标准
- 未提供
研究组 & 干预措施
Marketed paracetamol
Active Comparator
Marketed paracetamol
干预措施: Marketed paracetamol (Drug)
Experimental paracetamol formulation
Experimental
Experimental formulations
干预措施: Experimental paracetamol formulation (Drug)
结局指标
主要结局
Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states
时间窗: baseline to 10 hours post dose
次要结局
- Speed of absorption in fasted and semi-fed states(baseline to 10 hours post dose)
研究者
研究点 (1)
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