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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01653314
First Posted: July 31, 2012
Last Update Posted: July 31, 2012
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.
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
  Purpose
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
Healthy Drug: Megavec Drug: Glivec Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

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


Secondary Outcome Measures:
  • Pharmacokinetics
    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

  Eligibility

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
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01653314     History of Changes
Other Study ID Numbers: DW_MGV001
First Submitted: July 25, 2012
First Posted: July 31, 2012
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