JPRN-jRCTs071190031已完成未知
Investigation of correlation between DNA methylation in hepatic derived cells and CYP3A4 actibity in healthy volunteers
Yoshihara Tatsuya0 个研究点目标入组 20 人开始时间: 2019年10月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
Midazolam was administered to a subject whose DNA methylation frequency was determined using hepatocytes obtained from human peripheral blood. The results of this study indicate that the frequency of DNA methylation may be an indicator of CYP3A4 metabolic activity.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 45age old（—）
- 性别
- All
入选标准
- •1) Japanese healthy male or female who is capable to understand and sign the informed consent
- •2) 20-45 years of age
- •3) BMI 17.6-26.4
- •4) good health as determined by physical examination, vital signs and laboratory tests.
排除标准
- •1) history of allergy to any drugs
- •2) medical attention within 2 months prior to participation
- •3) donation of 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation
- •4) donation of 400 mL or more of blood within 12 weeks prior to participation
- •5) recent (past 4 months) participation in other clinical trial for investigational new chemical entity
- •6) history of drug abuse
- •7) alcohol abuse
- •8) taking drugs or healthy foods which may affect drug metabolism
研究者
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