Pharmacokinetics and pharmacodynamics of Tacrolimus and its metabolites at healthy Korean volunteers; the relationship with the CYP3A4 , CYP3A5, MDR-1 genotypes

Not Applicable

Completed

Conditions: Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism

Registration Number: KCT0001856

Lead Sponsor: Kyungpook National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 34

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

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures