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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01653314
First received: July 25, 2012
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  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
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders 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

No publications provided

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov 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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013