None listed
Conditions
Interventions
Drug : This will be an open label, randomized, single dose, 2*2 crossover study in adult healthy male. 50 subjects will be enrolled into the study. There will be 3 weeks washout period between doses.
Sponsors
Chong Kun Dang
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Signed the informed consent from prior to screening test 2. Between 19 years and 55 years in healthy male subject 3. Have not any congenital or chronic disease and medical symptoms 4. Body mass index(BMI) of 18 to 30 and a total body weight = 55kg 5. Appropriate subject for the study judging from investigator
Exclusion criteria
Exclusion criteria: 1. Evidence or history of clinically significant hepatic, renal, neurologic, immune system, respiratory system, endocrine 2. Any condition possibly affecting drug absorption (e.g. gastrectomy) 3. Subject with hypersensitivity to tacrolimus or any excipient 4. Administration of cyclosporin or bosentan 5. Administration of potassium-sparing diuretics 6. Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 7. SBP150 mmHg or DBP>100 mmHg at least 3 minutes of rest 8. A positive HBsAg, HCV Ab, HIV Ab, RPR 9. AST, ALT > 1.5*upper limit of normal range at the screening test 10 Subject with a history of drug abuse or a positive reaction for drug abuse at the screening test 11. Taking ETC medicine including oriental medicine within 14days before the first hospitalization or taking OTC medicine, vitamin within 7days 12. Use of any drugs known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initiation test 13. Participating in a bioequivalence study or other clinical study within 3 month preceding the first hospitalization 14. Blood donation or more within 2 month or component blood donation within 1 month prior to the first hospitalization 15. Continued to be drinking(alcohol> 21 units/week, 1 unit=10g of pure alcohol) or during clinical trials can not be drunk 16. Severe heavy smoker(cigarette> 10 cigarettes/day) during 3 months or can not be smoking during the clinical study 17. Continued to be taking caffeine or can not be taken caffeine 18. Continued to be taking grapefruit or can not be taken grapefruit 19. Not use of contraception during the clinical study 20. An impossible one who participates in the clinical trial by investigator's decision including for reason of laboratory test result
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast;Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf | — |
Countries
Korea, Republic of
Contacts
Public ContactLi Young Ahn
Seoul National University Hospital
Outcome results
None listed