healthy male and female
Conditions
Interventions
1) midazolam (oral)
2) midazolam (iv)
Sponsors
Yoshihara Tatsuya
Ieiri Ichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese healthy male or female who is capable to understand and sign the informed consent 2) 20-45 years of age 3) BMI 17.6-26.4 4) good health as determined by physical examination, vital signs and laboratory tests.
Exclusion criteria
Exclusion criteria: 1) history of allergy to any drugs 2) medical attention within 2 months prior to participation 3) donation of 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation 4) donation of 400 mL or more of blood within 12 weeks prior to participation 5) recent (past 4 months) participation in other clinical trial for investigational new chemical entity 6) history of drug abuse 7) alcohol abuse 8) taking drugs or healthy foods which may affect drug metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between DNA methylation in hepatic derived cells and midazolam pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between miRNA and protein in hepatic derived cells and midazolam pharmacokinetics Correlation between miRNA and protein in hepatic derived exosomes and midazolam pharmacokinetics Correlation between miRNA in urine derived exosomes and midazolam pharmacokinetics | — |
Contacts
Public ContactYukie Matsuzaki
Fukuoka Mirai Hospital
Outcome results
None listed