None listed
Conditions
Interventions
Drug : group by pharmaco-genotypes and single oral administration tacrolimus 0.075mg/kg for 30 subjects and a placebo 0.075mg/kg for 4 subjects
Sponsors
Kyungpook National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy Korean male subject aged 20 between 55 Subject without a problem of medical examination by interview, physical examination, ECG, hematology, clinical chemistry
Exclusion criteria
Exclusion criteria: The patient with chronic disease(diabetes, liver disease, hypertension, pancreatitis, cancer, chronic renal failure, etc.) The man with a history of such trauma, cerebrovascular disease, epilepsy or a seizure disorder The man with a history of Alcoholism, drug abuse and psychopathy The associated disease patient who are receiving administration of biological control agents, cytotoxic agents, systemic corticosteroids The man with decreased heart function, heart failure, chest pain, myocardial disabilities The man with bacterial, viral or serious fungal, protozoal infections The man is exceed the limit values set out in the KNUH clinical research centers in the physical examination and clinical pathology The man has more than 20% of the standard body weight in Korean characters The subject that is not eligible to participate at the discretion of study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tacrolimus metabolites;tacrolimus trough blood level therapeutic drug monitoring;calcineurin phosphatase activity;metabolites change of administration before and after the drug(amino acid metabolite profile / acylcarnitin metabolite profile .etc) | — |
Secondary
| Measure | Time frame |
|---|---|
| physical examination;vital sign;adverse event | — |
Countries
Korea, Republic of
Contacts
Public ContactHyun-Ju Cho
Kyungpook National University Hospital
Outcome results
None listed