Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Area under curve of metoclopramide (MCP)
研究概览
简要总结
Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to polymorphisms of CYP2D6
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 20 - 27kg/m2
- •Caucasians
- •Healthy volunteers
排除标准
- •Pregnancy/lactation period
- •Drug allergy
- •Acute and chronic diseases
- •Taking medication
- •Abuse of drugs, alcohol etc.
研究组 & 干预措施
Metoclopramide
Metoclopramide treatment
干预措施: Metoclopramide (Drug)
Diphenhydramine
Diphenhydramine treatment
干预措施: Diphenhydramine (Drug)
结局指标
主要结局
Area under curve of metoclopramide (MCP)
时间窗: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Pharmacokinetic of MCP at following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application
Area under curve of diphenhydramine(DPH)
时间窗: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Pharmacokinetics of DPH at following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application
次要结局
- Tmax of diphenhydramine(0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours)
- Cmax of metoclopramide(0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours)
- Tmax of metoclopramide(0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours)
- Cmax of diphenhydramine(0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours)
研究者
Matthias Schwab
Prof. M.D.
University Hospital Tuebingen