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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01653314
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : July 31, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Megavec Drug: Glivec Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : January 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Megavec Drug: Megavec
Drug: Glivec
Active Comparator: Glivec Drug: Megavec
Drug: Glivec

Primary Outcome Measures :
  1. Safety
    Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG

Secondary Outcome Measures :
  1. Pharmacokinetics
    AUC and Cmax in plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes 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

Responsible Party: Daewoong Pharmaceutical Co. LTD. Identifier: NCT01653314     History of Changes
Other Study ID Numbers: DW_MGV001
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action