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to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT01926548
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Brief Summary:
This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x 200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: CJ Imatinib mesylate tablet Drug: Gleevec film-coated tablet 2 x 100mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers
Study Start Date : February 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CJ Imatinib 200mg
1 tablet(200mg) a day,PO,QD
Drug: CJ Imatinib mesylate tablet
Active Comparator: Gleevec 100mg
2 tablet(100mg) a day,PO,QD
Drug: Gleevec film-coated tablet 2 x 100mg



Primary Outcome Measures :
  1. maximum concentration, Area under the concentration-time curve from zero to infinity [ Time Frame: Blood sampling up to 72hs post dose(16 times). ]
    Administration of IP : 1day


Secondary Outcome Measures :
  1. Time to peak concentration, t1/2, Area under the concentration-time curve from zero to infinity [ Time Frame: Blood sampling up to 72hs post dose(16 times). ]
    Administration of IP : 1 day



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:

  • Male volunteers in the age between 20 and 55 years old
  • Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
  • Body Mass Index (BMI) in the range of 18.5 to 27 kg/m2
  • Available for the entire study period
  • Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

  • History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
  • Clinically significant vital sign

    • SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 140 mmHg
    • DBP(Diastolic Blood Pressure) ≤ 60 mmHg or DBP ≥ 100 mmHg
  • History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
  • History of clinically significant allergies, including imatinib
  • Clinical laboratory test values are outside the accepted normal range

    • AST(ASpartate Transaminase), ALT(ALanine Transaminase)( > 1.5 times to normal range
    • Estimated GFR(Glomerular Filtration Rate) < 80 mL/min
  • History of caffeine, alcohol, smoking abuse

    • caffeine > 4 cups/day
    • grapefruit juice > 4 cups/day
    • smoking > 20 cigarettes/day
    • alcohol > 140g/week
  • Participated in a previous clinical trial within 3 months prior to dosing
  • Donated blood within 60 days prior to dosing
  • Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 10 days before dosing
  • Subjects considered as unsuitable based on medical judgement by investigators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926548


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
CJ HealthCare Corporation

Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT01926548     History of Changes
Other Study ID Numbers: CJ_IMM_101
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by CJ HealthCare Corporation:
Pharmacokinetics
Safety

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