Tacrobell tab_Phase1_PK

NCT ID: NCT02336854

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-12
• Study Completion Date: 2015-03-19

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.

Conditions

Immunosuppressant(Organ Transplantation, RA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrobell tab. 2mg

2mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover)

Group Type: EXPERIMENTAL

Tacrobell tab. 2mg

Intervention Type: DRUG

Prograf cap. 2mg

1mg/capsule, PO, 2 capsule once daily for Period I \& II D1(crossover)

Group Type: ACTIVE_COMPARATOR

Prograf cap. 2mg

Intervention Type: DRUG

Interventions

Tacrobell tab. 2mg

Intervention Type: DRUG

Prograf cap. 2mg

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

111HPS14027

Identifier Type: -

Identifier Source: org_study_id