none Healthy volunteer
Conditions
Interventions
The oral administration of Midazolam and Heliocare to healthy volunteer.
Sponsors
Sambe Takehiko
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age: 20-45 2) Male 3) BMI: 18.5 kg/m^2 or more and less than 30.0 kg/m^2 4) Those who have the ability to consent and who comply with the compliance items during research participation, who are able to undergo the pre-examination prescribed in this study implementation plan and report subjective symptoms etc. 5) Those who have been judged to be eligible to participate in this study by the doctor in charge of the study, etc. in the pre-examination prescribed in this study implementation plan.
Exclusion criteria
Exclusion criteria: 1)Patients who have a medical history (drug abuse/addiction, alcohol abuse/addiction, heart/liver/kidney/lung/eye/blood disease, etc.) that may affect the evaluation and safety of this study 2) Those who are taking drugs (including supplements and dietary supplements) that may affect the evaluation and safety of this study 3) Those with a history of drug allergy 4) Those who regularly use excessive alcohol (those who cannot maintain alcohol during the drug examination period) 5) Those who are within 3 months of participating in other clinical trials 6) Any other person who is judged to be ineligible for this study by the research doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of serum midazolam(AUC, Cmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of serum midazolam(t1/2, tmax) | — |
Countries
Japan, nnone
Contacts
Public ContactYuki Nishimura
Showa University
Outcome results
None listed