Megavec 400 mg (Imatinib Mesylate) in Healthy Adult Male Volunteers
- Registration Number
- NCT01653314
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Glivec Glivec - Glivec Megavec - Megavec Megavec - Megavec Glivec -
- Primary Outcome Measures
Name Time Method Safety Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG
- Secondary Outcome Measures
Name Time Method Pharmacokinetics AUC and Cmax in plasma