Megavec 400 mg (Imatinib Mesylate) in Healthy Adult Male Volunteers

A Randomized, Open-label, Single Dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess Safety and Pharmacokinetics of Megavec 400 mg (Imatinib Mesylate) Under Fasted Conditions in Healthy Male Subjects

The purpose of this Study is to Assess Safety and Pharmacokinetics of megavec 400 mg (Imatinib mesylate) under Fasted Conditions in Healthy Male Subjects.

• Inclusion Criteria:

  • Healthy and male subjects aged 20 to 55 years
  • The subject has a Body weight ≥55 kg and ideal body weight (IBW) within ±20%
  • A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
  • A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints.

• Exclusion Criteria:

  • A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, hematology, neurology and psychology function or other significant diseases and history
  • Known allergy or hypersensitivity to the study medication
  • AST or ALT greater than 1.25 times the upper limit of reference range or Total bilirubin greater than 1.25 times the upper limit of reference range base on screening results
  • A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests