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Tacrobell tab_Phase1_PK

C

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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