Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumors
Conditions
Keywords
Imatinib mesylate, Pharmacokinetics, Healthy volunteers
Brief summary
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
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.
Interventions
DRUGLuckyvec 400mg film coated tablet
•400mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover)
DRUGGlivec 100mg film coated tablet
•100mg/tablet, PO, 4 tablets once daily for Period I & II D1(crossover)
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects | 0-72hr |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed