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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Imatinib Mesylate

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