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

Daewoong Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Megavec

Drug: Glivec

Study type

Interventional

Funder types

Industry

Identifiers

NCT01653314

DW_MGV001

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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