JPRN-UMIN000008206已完成未知
The study to investigate the drug interaction via CYP3A between oral Midazolam administration and short term multiple Anchu-san dose in Japanese male subjects. - Drug interaction study between Midazolam and short term Anchu-san multiple dose.
Showa University School of Medicine Department of Clinical Pharmacology0 个研究点目标入组 12 人开始时间: 2012年6月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
This study was performed in 12 subjects. No adverse event was observed during the study in all subjects. No pronounced differences on PK parameter of plasma Midazolam between pre- and post dose of Anch-san were observed in both G2 and G16 group. No difference was also observed in VAS scale. It was suggested that 1 day oral Anchu-san administration would not prominently affect on PK of oral Midazolam dose. J. Showa Med Assoc.(in print)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 25years-old 至 40years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •1) Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs (including health supplements). 2) Any history for drug allergy 3) Subjects who are taking in too much alcohol (those who cannot maintain the abstains from alcohol during study period) 4) Subjects within three months after the participation to other clinical trials 5) Subjects who are inadequate for enrollment judged by the investigator.
研究者
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