Tacrobell tab_Phase1_PK

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.

Study Overview

• Status: Completed
• Conditions: Immunosuppressant(Organ Transplantation, RA)
• Intervention / Treatment: Drug: Tacrobell tab. 2mg; Drug: Prograf cap. 2mg

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUClast	up to 96 hous postdose
Cmax	up to 96 hous postdose

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2015
• Primary Completion (Actual): February 2, 2015
• Study Completion (Actual): March 19, 2015

Study Registration Dates

• First Submitted: January 8, 2015
• First Submitted That Met QC Criteria: January 12, 2015
• First Posted (Estimate): January 13, 2015

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: 111HPS14027