Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC
研究概览
简要总结
Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol and antiepileptic drugs before and 6 months after sleeve gastrectomy.
详细描述
Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol (in consenting subjects that are undergoing sleeve gastrectomy) and antiepileptic drugs (in consenting subjects that are chronically treated by a stable dose) before and 6 months after sleeve gastrectomy in 10 subjects.
Blood tests will be taken for drug levels before and 4-8 times after the subject takes the drug. A pharmacokinetic curve will be calculated and compared for each subject between prior to surgery and after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI over 30 and eligible for sleeve gastrectomy
- •Mentally capable for consent
- •(for the antiepileptic drug intervention) chronic stable treatment of antiepileptic drug
排除标准
- •Gastrointestinal illness impairing absorption
- •renal failure (glomerular filtration rate<45)
- •liver cirrhosis
- •heart failure (New York Heart Association class III or IV)
研究组 & 干预措施
paracetamol
10 participants will undergo measurement of paracetamol levels before and after sleeve gastrectomy
干预措施: Paracetamol (Drug)
antiepileptic drug
Up to 10 participants in each drug (up to 4 medications, total of up to 40 participants) will undergo measurement of levels of their chronic medication after a dose before and after sleeve gastrectomy
干预措施: Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid) (Drug)
结局指标
主要结局
Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC
时间窗: 8 hours
sequential measurement of paracetamol or antiepileptic drug (carbamazepine, lamotrigine, phenytoin or valproic acid), AUC
次要结局
未报告次要终点
研究者
Irit HOCHBERG MD
Principle investigator, Attending physician in Institute of Endocrinology, Diabetes and Metabolism
Rambam Health Care Campus