Tacrobell tab_Phase1_PK

Inclusion criteria

• Understand the requirements of the study and voluntarily consent to participate in the study.
• Healthy male volunteer in the age between 20 and 45 years old.
• Body weight ≥ 55 kg and 30.0kg/m2 ≥ BMI ≥ 18.0kg/m2

Exclusion criteria

• presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
• any chronic disease which might interfere with resorption, distribution, metabolism or excretion of the drug, or major surgery of the gastrointestinal tract except for appendectomy
• any history of drug hypersensitivity (especially to the active and inactive ingredients of the tacrolimus preparation)
• administration of cyclosporine or Bosentan
• administration of potassium sparing diuretic
• Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• SBP > 150 mmHg or< 90 mmHg
• DBP > 100 mmHg or < 50 mmHg
• positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies, RPR
• AST or ALT > 1.5*ULN, e-GFR < 80 mL/min
• history of drug abuse or positive drug screening test
• intake or administration of any ethical or herbal medication medication within 2 weeks, intake or administration of any OTC or vitamin preparations
• medication with metabolizing enzyme inducers or inhibitors such as barbitals within 1 month before first dosing
• administration of another study medications within 3 months before first dosing
• blood donation in 2 months, component blood donation within 1 month or blood transfusion before first dosing
• Alcohol > 21 units/week or cannot stop drinking during the study
• Cigarette > 10 cigarettes/day or cannot stop smoking during hospitalization
• consumption of beverages or food containing caffeine(e.g.coffee, tea) during hospitalization
• consumption of grapefruit or food containing grapefruit during hospitalization
• Not eligible to participate for the study at the discretion of investigator.