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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Male

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.

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

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
• Treatments: Imatinib Mesylate

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