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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luckyvec 400mg film coated tablet | Experimental | 400mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover) |
|
| Glivec 100mg film coated tablet | Active Comparator | 100mg/tablet, PO, 4 tablets once daily for Period I & II D1(crossover) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luckyvec 400mg film coated tablet | Drug | •400mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects | 0-72hr |
| 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 |
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Inclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Ji-Young Park | jypark21@korea.ac.kr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Korea University Anam Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24060561 | Derived | Kim KA, Park SJ, Kim C, Park JY. Single-dose, randomized crossover comparisons of different-strength imatinib mesylate formulations in healthy Korean male subjects. Clin Ther. 2013 Oct;35(10):1595-602. doi: 10.1016/j.clinthera.2013.08.008. Epub 2013 Sep 21. |
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| Glivec 100mg film coated tablet | Drug | •100mg/tablet, PO, 4 tablets once daily for Period I & II D1(crossover) |
|
|
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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