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

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Completed
CT.gov ID
NCT01653314
Collaborator
(none)
40
Enrollment
2
Arms
2
Duration (Months)

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Jan 1, 2012
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Megavec

Drug: Megavec

Drug: Glivec
Active Comparator: Glivec

Drug: Megavec

Drug: Glivec

Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01653314
Other Study ID Numbers:
  • DW_MGV001
First Posted:
Jul 31, 2012
Last Update Posted:
Jul 31, 2012
Last Verified:
Jul 1, 2012
Additional relevant MeSH terms:
Imatinib Mesylate

Study Results

No Results Posted as of Jul 31, 2012