A pilot study to investigate the drug interaction via CYP3A between oral Midazolam administration and miltiple Anchusan dose in Janaese male subjects. - Drug interaction study between Midazolam and Anchusan.

Showa University School of Medicine Department of Clinical Pharmacology0 个研究点目标入组 3 人开始时间: 2011年11月10日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 3

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

This pilot study was performed in two subjects. No adverse event was observed during the study in all subjects. Mean value of PK parameter of plasma Midazolam are as follows; Pre-dose of Anchu-san Cmax:112.34 ng/mL, AUC:418.94 nghr/mL After 7 days Anchu-san dose Cmax:166.85 ng/mL, AUC:528.94 nghr/mL No difference was observed in VAS scale between pre- and post- Anchu-san dose. It was suggested that 7 days oral Anchu-san administration would affect on PK of oral Midazolam dose. The verification study will be conducted with increased number of study subjects.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 45years-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

发起方

Showa University School of Medicine Department of Clinical Pharmacology

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The study to investigate the drug interaction via CYP3A between oral Midazolam administration and short term multiple Anchu-san dose in Japanese male subjects.

JPRN-UMIN000008206Showa University School of Medicine Department of Clinical Pharmacology12