Tacrobell tab_Phase1_PK

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Immunosuppressant(Organ Transplantation, RA)

Treatments: Drug: Tacrobell tab. 2mg; Drug: Prograf cap. 2mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02336854

111HPS14027

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Tacrobell tab. 2mg

Experimental group

Description:

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

Treatment:

Drug: Tacrobell tab. 2mg

Prograf cap. 2mg

Active Comparator group

Description:

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

Treatment:

Drug: Prograf cap. 2mg