Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Morbidly Obese Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients.
研究概览
简要总结
This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients versus normal weight patients. Specifically the different metabolic pathways of acetaminophen in morbidly obese adults will be investigated; glucuronidation, sulphation and CYP2E1 (cytochrome P450 2E1) oxidation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
normal weight patients
normal weight patients receiving acetaminophen 2 g instead of 1 g
干预措施: acetaminophen 2 g (Drug)
mobidly obese patients
morbidly obese patients receiving acetaminophen 2 g instead of 1 g
干预措施: acetaminophen 2 g (Drug)
结局指标
主要结局
Volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients.
时间窗: 24 hours
Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) of acetaminophen in morbidly obese patients in comparison with normal weight patients.
时间窗: 24 hours
次要结局
- Difference in clearance (total, glucuronidation, sulphation, CYP2E1 oxidation) of acetaminophen in morbidly obese patients at the time of bariatric surgery and at 0.5 - 2 year after bariatric surgery.(8 hours)
- Difference in volume of distribution of acetaminophen in morbidly obese patients at the time of bariatric surgery and at 0.5 - 2 year after bariatric surgery.(8 hours)
- Liver function tests in morbidly obese patients in comparison with normal weight patients.(24 hours)
研究者
Catherijne Knibbe
Prof. dr.
St. Antonius Hospital