Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects (Imatinib)

Chong Kun Dang

Status and phase

Completed

Phase 1

Conditions

Gastrointestinal Stromal Tumors

Chronic Myeloid Leukemia

Treatments

Drug: Luckyvec 400mg film coated tablet

Drug: Glivec 100mg film coated tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01270984

131HPS10D

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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