Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T) when administered a single-dose to healthy volunteers.

Detailed Description
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Healthy volunteers are administrated single-dose over the period I and II (Crossover) of Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T)as of Imatinib 400mg. Every time before and after each medication, PK parameters and safety of Luckyvec 400mg tablet and Glivec 100mg is performed using a blood sample and conducting some tests(Laboratory test, V/S, Physical Examination, etc) respectively.

Official Title
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Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects

Conditions
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Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumors

Intervention / Treatment
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* Drug: Luckyvec 400mg film coated tablet
* Drug: Glivec 100mg film coated tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 20 aged and 45 aged in healthy males BMI: 18 29.9 kg/m2, (BMI = (체중 [kg])/(height [m])2) Agreement with written informed consent Exclusion Criteria: Clinically significant cardiovascular system, pulmonary system, liver system, renal system, blood system, gastrointestinal system, immune system, skin system, nervous system or mental disease(Past history or present) Subject with symptoms of acute disease within 28 days of starting administration of investigational drug Subject with known for history which affect on the ADME of drug Clinically significant active chronic disease Inadequate result of laboratory test AST/ALT > 1.5 x UNL Total bilirubin > 1.5 x UNL Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test Taking ETC(ethical the counter)medicine within 14 days Taking OTC(Over the counter)medicine including oriental medicine within 7 days Clinically significant allergic disease(Except for mild allergic rhinitis and dermatits seems to be not need for medication) Subject with known for hypersensitivity reaction to imatinib analog Not able to taking the institutional standard meal Previously make whole blood donation within 60 days or component blood donation within 20 days Previously have blood transfusion within 30 days Previously participated in other trial within 30 days Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day) An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Ages Eligible for Study
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Minimum Age: 20 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: Luckyvec 400mg film coated tablet<br>400mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover) | Drug: Luckyvec 400mg film coated tablet<br>* •400mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover)<br>* Other names: Luckyvec;|
| Active Comparator: Glivec 100mg film coated tablet<br>100mg/tablet, PO, 4 tablets once daily for Period I & II D1(crossover) | Drug: Glivec 100mg film coated tablet<br>* •100mg/tablet, PO, 4 tablets once daily for Period I & II D1(crossover)<br>* Other names: Glivec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects |  | 0-72hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of Luckyvec 400mg tablet and Glivec 100mg tablet from vital signs, physical exam, ECG, laboratory test, adverse event and so on. |  | 0-72hr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imatinib mesylate, Pharmacokinetics, Healthy volunteers