We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT01653314
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : July 31, 2012
Sponsor:
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
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov 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