Immunosuppressant(Organ Transplantation, RA)
Conditions
Keywords
pharmacokinetics
Brief summary
A randomized, open-label, two-way crossover study to assess the tolerability and pharmacokinetics of Tacrobell® Tab. and Prograf® Cap. after a single oral dose in healthy male volunteers.
Interventions
DRUGTacrobell tab. 2mg
DRUGPrograf cap. 2mg
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Understand the requirements of the study and voluntarily consent to participate in the study. 2. Healthy male volunteer in the age between 20 and 45 years old. 3. Body weight ≥ 55 kg and 30.0kg/m2 ≥ BMI ≥ 18.0kg/m2
Exclusion criteria
1. presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases 2. 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 3. any history of drug hypersensitivity (especially to the active and inactive ingredients of the tacrolimus preparation) 4. administration of cyclosporine or Bosentan 5. administration of potassium sparing diuretic 6. Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 7. SBP \> 150 mmHg or\< 90 mmHg 8. DBP \> 100 mmHg or \< 50 mmHg 9. positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies, RPR 10. AST or ALT \> 1.5\*ULN, e-GFR \< 80 mL/min 11. history of drug abuse or positive drug screening test 12. intake or administration of any ethical or herbal medication medication within 2 weeks, intake or administration of any OTC or vitamin preparations 13. medication with metabolizing enzyme inducers or inhibitors such as barbitals within 1 month before first dosing 14. administration of another study medications within 3 months before first dosing 15. blood donation in 2 months, component blood donation within 1 month or blood transfusion before first dosing 16. Alcohol \> 21 units/week or cannot stop drinking during the study 17. Cigarette \> 10 cigarettes/day or cannot stop smoking during hospitalization 18. consumption of beverages or food containing caffeine(e.g.coffee, tea) during hospitalization 19. consumption of grapefruit or food containing grapefruit during hospitalization 20. Not eligible to participate for the study at the discretion of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast | up to 96 hous postdose |
| Cmax | up to 96 hous postdose |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf | up to 96 hous postdose |
| Tmax | up to 96 hous postdose |
| t1/2 | up to 96 hous postdose |
| CL/F | up to 96 hous postdose |
Outcome results
None listed