Tacrobell tab_Phase1_PK

• Status: Completed
• Trial end date: 2015-03-19
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Tacrolimus

Criteria

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.