Bioequivalence study of Tacrobell Capsule 1mg to Prograf Capsule 1mg

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 50

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

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. SBP<90 mmHg or DBP<50 mmHg, SBP>150 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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUClast;Cmax

Secondary Outcome Measures

Name	Time	Method
AUCinf

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