NCT01902342已完成1 期
A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Pharmacokinetic Characteristics of Oseltamivir in Healthy Korean Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Oseltamivir pharmacokinetic parameters
研究概览
简要总结
Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy Korean volunteers.
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects:
- •Agreement with written informed consent
- •Adult healthy male or female subject age 20 to 45
排除标准
- •Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
- •Medication with any drug which may affect the pharmacokinetics of oseltamivir within 14 days
- •Previously donate whole blood within 30 days or Previously participated in other trial within 60 days
- •Subject with known for hypersensitivity reactions to oseltamivir
- •Subject who perform contraception during study periods
- •Female woman who are pregnant or are breast feeding
- •An impossible one who participates in clinical trial by investigator's decision including laboratory test result
研究组 & 干预措施
CES1 gene variant group
Experimental
Oseltamivir 75 mg 1 cap
干预措施: Oseltamivir 75 mg 1 cap (Drug)
CES1 gene wild type group
Experimental
Oseltamivir 75 mg 1 cap
干预措施: Oseltamivir 75 mg 1 cap (Drug)
结局指标
主要结局
Oseltamivir pharmacokinetic parameters
时间窗: Up to 0 to 48 h post dose
Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf)
Oseltamivir carboxylate pharmacokinetic parameters
时间窗: Up to 0 to 48 h post dose
Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf)
次要结局
- Other oseltamivir pharmacokinetic parameters(Up to 0 to 48 h post dose)
- Other oseltamivir carboxylate pharmacokinetic parameters(Up to 0 to 48 h post dose)
研究者
研究点 (1)
Loading locations...
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