Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
NCT ID: NCT01270984
Last Updated: 2012-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2010-11-30
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Luckyvec 400mg film coated tablet
400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover)
Luckyvec 400mg film coated tablet
•400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover)
Glivec 100mg film coated tablet
100mg/tablet, PO, 4 tablets once daily for Period I \& II D1(crossover)
Glivec 100mg film coated tablet
•100mg/tablet, PO, 4 tablets once daily for Period I \& II D1(crossover)
Interventions
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Luckyvec 400mg film coated tablet
•400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover)
Glivec 100mg film coated tablet
•100mg/tablet, PO, 4 tablets once daily for Period I \& II D1(crossover)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI: 18\~29.9 kg/m2, (BMI = (체중 \[kg\])/(height \[m\])2)
* Agreement with written informed consent
Exclusion Criteria
* 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
20 Years
45 Years
MALE
Yes
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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The Korea University Anam Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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131HPS10D
Identifier Type: -
Identifier Source: org_study_id