NCT01519726已完成4 期
CYP3A4 Metabolism Before and After Surgery Induced Weight Loss in Morbidly Obese Patients Using Midazolam as a Model Drug
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery
研究概览
简要总结
Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing bariatric surgery
排除标准
- •use of drug inducing or inhibiting CYP3A4 activity
- •pregnancy, breastfeeding
- •renl insufficiency
研究组 & 干预措施
Morbidly obese patients
Experimental
干预措施: Midazolam (Drug)
结局指标
主要结局
Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery
时间窗: 0.5-2 years
次要结局
未报告次要终点
研究者
Catherijne Knibbe
Professor in Pharmacology, Hospital pharmacist
St. Antonius Hospital
研究点 (1)
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