Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
20 Years
45 Years
Male
Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumors
Trial Information
Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects
Outcome Time Frame:
0-72hr
Safety Issue:
No
Principal Investigator
Ji-Young Park
Investigator Role:
Principal Investigator
Investigator Affiliation:
jypark21@korea.ac.kr
Authority:
Korea: Food and Drug Administration
Study ID:
131HPS10D
NCT ID:
NCT01270984
Start Date:
November 2010
Completion Date:
December 2010
Related Keywords:
- Chronic Myeloid Leukemia
- Gastrointestinal Stromal Tumors
- Imatinib mesylate
- Pharmacokinetics
- Healthy volunteers
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Gastrointestinal Stromal Tumors
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