NCT01540721已完成1 期
A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Different Sustained Released 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
- Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state
研究概览
简要总结
This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.
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 health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
排除标准
- •Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism, excluding prescription birth control, if applicable.
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
Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state
时间窗: baseline to 12 hours
Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax
时间窗: baseline to 12 hours
次要结局
- To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC)(baseline to 12 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®Healthy SubjectsNCT01540734GlaxoSmithKline28
已完成
1 期
Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)Acute PainNCT05406752Unither Pharmaceuticals, France32
撤回
1 期
A Study to Compare Two Paracetamol TabletsHealthy SubjectsNCT01381640GlaxoSmithKline
已完成
1 期
Study of GSK3511294 in Healthy Chinese ParticipantsAsthmaNCT05140200GlaxoSmithKline20
已完成
1 期
Bioavailability Study of 3 Tablet Formulations vs. Capsule Formulation of JNJ-56021927 in Fasting Healthy Male ParticipantsHealthyNCT02160756Aragon Pharmaceuticals, Inc.75