NCT01540734已完成1 期
A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release 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
- 28
- 试验地点
- 1
- 主要终点
- To compare bioavailability as measured by Area under the Curve in both fed and fasted states
研究概览
简要总结
A single dose pharmacokinetic study investigating two 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
- •Good general heatlh with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
排除标准
- •Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the remainder of the study.
- •Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- •Current (within 14 days of screening) or regular use of any prescription, over the counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.
研究组 & 干预措施
Marketed paracetamol
Active Comparator
marketed formulation
干预措施: Marketed paracetamol (Drug)
Experimental paracetamol formulation
Experimental
Experimental formulation
干预措施: Experimental paracetamol formulation (Drug)
结局指标
主要结局
To compare bioavailability as measured by Area under the Curve in both fed and fasted states
时间窗: Visit 1 through Visit 3 (Day 13)
To assess the effect of food on extent and rate of paracetamol absorption as measured by Area Under the Curve and Cmax
时间窗: Visit 1 through Visit 3 (Day 13)
次要结局
- To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax)(Visit 1 through Visit 3 (Day 13))
研究者
研究点 (1)
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