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

This study has been completed.
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD. Identifier:
First received: July 25, 2012
Last updated: July 26, 2012
Last verified: July 2012
The purpose of this Study is to Assess Safety and Pharmacokinetics of megavec 400 mg (Imatinib mesylate) under Fasted Conditions in Healthy Male Subjects.

Condition Intervention Phase
Drug: Megavec
Drug: Glivec
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
    Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG

Secondary Outcome Measures:
  • Pharmacokinetics [ Designated as safety issue: No ]
    AUC and Cmax in plasma

Enrollment: 40
Study Start Date: January 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Megavec Drug: Megavec Drug: Glivec
Active Comparator: Glivec Drug: Megavec Drug: Glivec


Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Daewoong Pharmaceutical Co. LTD. Identifier: NCT01653314     History of Changes
Other Study ID Numbers: DW_MGV001 
Study First Received: July 25, 2012
Last Updated: July 26, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Imatinib Mesylate
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors processed this record on May 24, 2016