Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Proguanil pharmacokinetics. Primary endpoint is cycloguanil formation clearance.
研究概览
简要总结
The aim of this study is to investigate if the genetic variant CYP2C19*17 affects the pharmacokinetics of proguanil and clopidogrel.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Written consent
- •Age 18-65
- •CYP2C19*1 and or CYP2C19*17 genotype.
排除标准
- •Daily medication
- •Alcohol abuse
- •Pregnancy
- •Breastfeeding
研究组 & 干预措施
Period A: proguanil
Proguanil pharmacokinetics
干预措施: Proguanil (Drug)
Period B: clopidogrel
Clopidogrel pharmacokinetics
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Proguanil pharmacokinetics. Primary endpoint is cycloguanil formation clearance.
时间窗: Hours after administration: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 10, 24, 31, 48, 55
Based on blood- and urine-concentrations of proguanil and the metabolites cycloguanil and 4-chlorphenylbiguanid a comparison of the pharmacokinetic parameters (AUC, Cmax, Tmax, T1/2) between the three groups of genotypes (CYP2C19\*1/\*1, CYP2C19\*1/\*17 and CYP2C19\*17/\*17) will be made.
次要结局
- Pharmacokinetics of the derivatised active clopidogrel metabolite.(Hours after administration: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7)
研究者
Rasmus Steen Pedersen
Assistant Professor
University of Southern Denmark