Clinical trial NCT01270984: Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
Official title: Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Myeloid Leukemia
Gastrointestinal Stromal Tumors
Keywords: Imatinib mesylate
Pharmacokinetics
Healthy volunteers
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-01-06
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects
timeFrame: 0-72hr
Secondary outcomes:
measure: 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.
timeFrame: 0-72hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Korea University Anam Hospital
Study officials:
affiliation: jypark21@korea.ac.kr
name: Ji-Young Park
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.