Tacrobell tab_Phase1_PK

Study Overview
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Brief Summary
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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
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Immunosuppressant(Organ Transplantation, RA)

Intervention / Treatment
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* Drug: Tacrobell tab. 2mg
* Drug: Prograf cap. 2mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understand the requirements of the study and voluntarily consent to participate in the study. Healthy male volunteer in the age between 20 and 45 years old. Body weight ≥ 55 kg and 30.0kg/m2 ≥ BMI ≥ 18.0kg/m2 Exclusion Criteria: presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases 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 any history of drug hypersensitivity (especially to the active and inactive ingredients of the tacrolimus preparation) administration of cyclosporine or Bosentan administration of potassium sparing diuretic Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption SBP > 150 mmHg or< 90 mmHg DBP > 100 mmHg or < 50 mmHg positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies, RPR AST or ALT > 1.5*ULN, e-GFR < 80 mL/min history of drug abuse or positive drug screening test intake or administration of any ethical or herbal medication medication within 2 weeks, intake or administration of any OTC or vitamin preparations medication with metabolizing enzyme inducers or inhibitors such as barbitals within 1 month before first dosing administration of another study medications within 3 months before first dosing blood donation in 2 months, component blood donation within 1 month or blood transfusion before first dosing Alcohol > 21 units/week or cannot stop drinking during the study Cigarette > 10 cigarettes/day or cannot stop smoking during hospitalization consumption of beverages or food containing caffeine(e.g.coffee, tea) during hospitalization consumption of grapefruit or food containing grapefruit during hospitalization Not eligible to participate for the study at the discretion of investigator.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrobell tab. 2mg<br>2mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover) | Drug: Tacrobell tab. 2mg<br> <br> |
| Active Comparator: Prograf cap. 2mg<br>1mg/capsule, PO, 2 capsule once daily for Period I & II D1(crossover) | Drug: Prograf cap. 2mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | up to 96 hous postdose | 
| Cmax |  | up to 96 hous postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf |  | up to 96 hous postdose | 
| Tmax |  | up to 96 hous postdose | 
| t1/2 |  | up to 96 hous postdose | 
| CL/F |  | up to 96 hous postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics