healthy male
Conditions
Interventions
1. Single oral dose of tacrolimus hydrate, valacyclovir hydrochloride, candesartan cilexetil
2. Single oral dose of probiotics containing Bacillus subtilis, tacrolimus hydrate, valacyclovir hydrochlor
Sponsors
Yoshihara Tatsuya
Ieiri Ichiro
Department of Pharmacy, Kyushu University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese healthy male 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 |
|---|---|
| 1. blood drug concentration (tacrolimus, valacyclovir, candesartan cilexetil and their major metabolites) 2. pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, CL, etc.) | — |
Contacts
Public ContactYukitoshi Mine
SOUSEIKAI Fukuoka Mirai Hospital
Outcome results
None listed