Development of High-throughput Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Cmax, AUC
研究概览
简要总结
The investigators objectives were developing mini dose five-drug cocktail regimen to evaluate potential drug-drug interactions associated with use of a cocktail of caffeine, losartan, omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A activities.
详细描述
The investigators objectives were developing minidose five-drug cocktail regimen to evaluate potential drug-drug interactions associated with use of a cocktail of caffeine, losartan, omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject whose CYP2C9, CYP2C19, CYP2D6 genotype was determined
排除标准
- •Subject who has abnormal laboratory test results
研究组 & 干预措施
Omeprazole
干预措施: Omeprazole (Drug)
Omeprazole
干预措施: Cocktail (Drug)
Losartan
干预措施: Losartan (Drug)
Losartan
干预措施: Cocktail (Drug)
Dextromethorphan
干预措施: Dextromethorphan (Drug)
Dextromethorphan
干预措施: Cocktail (Drug)
Caffeine
干预措施: Cocktail (Drug)
Caffeine
干预措施: Caffeine (Drug)
Midazolam
干预措施: Cocktail (Drug)
Midazolam
干预措施: Midazolam (Drug)
结局指标
主要结局
Cmax, AUC
时间窗: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose
次要结局
未报告次要终点
研究者
Jae-Gook Shin
Department of Pharmacology and Pharmacogenomics Research Center
Inje University