A verification study to investigate the drug interaction via CYP3A between oral Midazolam administration and miltiple Anchusan dose in Janaese male subjects.
- Conditions
- Japanese healthy male
- Registration Number
- JPRN-UMIN000007982
- Lead Sponsor
- Showa University School of Medicine Department of Clinical Pharmacology
- Brief Summary
This study was performed in 7 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:64.99+/-18.61ng/mL, AUC:192.59+/-78.13ng*hr/mL After 7 days Anchu-san dose Cmax:88.66+/-16.37ng/mL, AUC:249.06+/-72.84ng*hr/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. J. Showa Med Assoc.(in print)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 6
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 The pharmacokinetic parameters of midazolam in serum (AUC 0-10, Cmax, t1/2, tmax).
- Secondary Outcome Measures
Name Time Method The sedative action after midazolam oral administration: VAS Safety assessment (pulse oximeter, vital measurement, adverse event)