Clinical trial NCT02336854: Tacrobell tab_Phase1_PK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immunosuppressant(Organ Transplantation, RA)
Keywords: pharmacokinetics
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 50
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: AUClast
timeFrame: up to 96 hous postdose
measure: Cmax
timeFrame: up to 96 hous postdose
Secondary outcomes:
measure: AUCinf
timeFrame: up to 96 hous postdose
measure: Tmax
timeFrame: up to 96 hous postdose
measure: t1/2
timeFrame: up to 96 hous postdose
measure: CL/F
timeFrame: up to 96 hous postdose
Other outcomes:
Locations:
Study officials:
References: