to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers

Study Overview
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Brief Summary
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This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x 200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers.

Official Title
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Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: CJ Imatinib mesylate tablet
* Drug: Gleevec film-coated tablet 2 x 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male volunteers in the age between 20 and 55 years old Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data Body Mass Index (BMI) in the range of 18.5 to 27 kg/m2 Available for the entire study period Willing to adhere to protocol requirements and sign a informed consent form Exclusion Criteria: History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease Clinically significant vital sign SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 140 mmHg DBP(Diastolic Blood Pressure) ≤ 60 mmHg or DBP ≥ 100 mmHg History of surgery except or gastrointestinal disease which might significantly change absorption of medicines History of clinically significant allergies, including imatinib Clinical laboratory test values are outside the accepted normal range AST(ASpartate Transaminase), ALT(ALanine Transaminase)( > 1.5 times to normal range Estimated GFR(Glomerular Filtration Rate) < 80 mL/min History of caffeine, alcohol, smoking abuse caffeine > 4 cups/day grapefruit juice > 4 cups/day smoking > 20 cigarettes/day alcohol > 140g/week Participated in a previous clinical trial within 3 months prior to dosing Donated blood within 60 days prior to dosing Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 10 days before dosing Subjects considered as unsuitable based on medical judgement by investigators

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJ Imatinib 200mg<br>1 tablet(200mg) a day,PO,QD | Drug: CJ Imatinib mesylate tablet<br> <br> |
| Active Comparator: Gleevec 100mg<br>2 tablet(100mg) a day,PO,QD | Drug: Gleevec film-coated tablet 2 x 100mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum concentration, Area under the concentration-time curve from zero to infinity | Administration of IP : 1day | Blood sampling up to 72hs post dose(16 times). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to peak concentration, t1/2, Area under the concentration-time curve from zero to infinity | Administration of IP : 1 day | Blood sampling up to 72hs post dose(16 times). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Safety