Japanese healthy male
Conditions
Interventions
Midazolam single oral administration at 2 hours after three times repeated dose of 2.5g Anchu-san
Midazolam single oral administration at 16 hours after three times repeated dose of 2.5g Anchu-san
Sponsors
Showa University School of Medicine Department of Clinical Pharmacology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age: 20 - 45 years old at the time of informed consent 2)Sex: male 3) Subjects are competent to consent, keep the rules of the study and are able to report self condition. 4) Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pharmacokinetics parameter of midazolam in serum (AUC 0-8), Cmax, t1/2, tmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The sedative action after midazolam oral administration: VAS 2. Safety assessment (pulse oximeter, vital measurement, adverse event) | — |
Countries
Japan
Contacts
Public ContactTakehiko Sanbe MD
Showa University School of Medicine Department of Clinical Pharmacology
Outcome results
None listed