The study to investigate the drug interaction via CYP3A between oral Midazolam administration and short term multiple Anchu-san dose in Japanese male subjects.
- Conditions
- Japanese healthy male
- Registration Number
- JPRN-UMIN000008206
- Lead Sponsor
- Showa University School of Medicine Department of Clinical Pharmacology
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 12
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method