A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)

A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400 mg (1 Tablet) and Glivec Film-coated Tablet 100 mg (4 Tablets) After Oral Administration in Healthy Male Subjects (Phase I)

1. Investigational Product

   1. Imatinib mesylate tablet 400 mg
   2. Glivec film-coated tablet 100 mg (Comparator)

2. Expected target disease

   1. chronic myeloid leukemia
   2. Gastrointestinal stromal tumors

3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover study

   1. 36 healthy subjects, 2 groups (18 subjects/group)
   2. 2 Period (either 1-a(1 tablet) or 1-b(4 tablet))
   3. wash-out period : 14 days

4. Evaluation on pharmacokinetics(PKs) and safety

   1. PKs : Cmax, AUClast, Tmax, AUCinf, t1/2
   2. safety : adverse events, physical examination, vital sign, ECG, Laboratory test

5. Statistical method

   1. Demography Characteristics
   2. Pharmacokinetic parameters
   3. Safety data

Inclusion Criteria:

• healthy male volunteers between the ages of 20 to 50 years old
• weight more than 55kg and within the range of ±20% of ideal body weight (IBW)
• having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
• doctor determines to be suitable as subjects within 3 weeks ago before administration

Exclusion Criteria:

• Hypersensitivity(or history of hypersensitivity) to medicines including imatinib mesylate
• Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
• Creatinine clearance < 80 mL/min
• Gastrointestinal diseases or surgeries that affect absorption of drug
• Excessive drinking(exceed 21units/week)
• Smoking over 10 cigarettes per day