Healthy
Conditions
Brief summary
The purpose of this Study is to Assess Safety and Pharmacokinetics of megavec 400 mg (Imatinib mesylate) under Fasted Conditions in Healthy Male Subjects.
Interventions
DRUGMegavec
DRUGGlivec
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | — | Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | — | AUC and Cmax in plasma |
Outcome results
None listed