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A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)

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ClinicalTrials.gov Identifier: NCT01751919
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Brief Summary:
  1. Investigational Product

    1. Imatinib mesylate tablet 400 mg
    2. Glivec film-coated tablet 100 mg (Comparator)
  2. Expected target disease

    1. chronic myeloid leukemia
    2. Gastrointestinal stromal tumors
  3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover study

    1. 36 healthy subjects, 2 groups (18 subjects/group)
    2. 2 Period (either 1-a(1 tablet) or 1-b(4 tablet))
    3. wash-out period : 14 days
  4. Evaluation on pharmacokinetics(PKs) and safety

    1. PKs : Cmax, AUClast, Tmax, AUCinf, t1/2
    2. safety : adverse events, physical examination, vital sign, ECG, Laboratory test
  5. Statistical method

    1. Demography Characteristics
    2. Pharmacokinetic parameters
    3. Safety data

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Gastrointestinal Stromal Tumor Drug: Imatinib mesylate tablet 400 mg, 1 Tablet Drug: Glivec film-coated tablet 100 mg, 4 Tablets Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400 mg (1 Tablet) and Glivec Film-coated Tablet 100 mg (4 Tablets) After Oral Administration in Healthy Male Subjects (Phase I)
Study Start Date : May 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012


Arm Intervention/treatment
Group 1 (RT)
  • Period 1: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)
  • Period 2: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)
Drug: Imatinib mesylate tablet 400 mg, 1 Tablet Drug: Glivec film-coated tablet 100 mg, 4 Tablets
Group 2 (TR)
  • Period 1: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)
  • Period 2: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)
Drug: Imatinib mesylate tablet 400 mg, 1 Tablet Drug: Glivec film-coated tablet 100 mg, 4 Tablets



Primary Outcome Measures :
  1. Maximum concentration in plasma (Cmax) of Imatinib mesylate [ Time Frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose ]
  2. Area under the plasma concentration-time curve from zero time until the last measurable concentration (AUClast) of Imatinib mesylate [ Time Frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose ]

Secondary Outcome Measures :
  1. Time to Cmax (Tmax) of Imatinib mesylate [ Time Frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose ]
  2. Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of Imatinib mesylate [ Time Frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose ]
  3. Terminal Elimination Half-life (t1/2) of Imatinib mesylate [ Time Frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male volunteers between the ages of 20 to 50 years old
  • weight more than 55kg and within the range of ±20% of ideal body weight (IBW)
  • having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
  • doctor determines to be suitable as subjects within 3 weeks ago before administration

Exclusion Criteria:

  • Hypersensitivity(or history of hypersensitivity) to medicines including imatinib mesylate
  • Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
  • Creatinine clearance < 80 mL/min
  • Gastrointestinal diseases or surgeries that affect absorption of drug
  • Excessive drinking(exceed 21units/week)
  • Smoking over 10 cigarettes per day

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): NCT01751919


Locations
Korea, Republic of
Kyungpook National University
Daegu, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.

Publications:
Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01751919     History of Changes
Other Study ID Numbers: Imatinib_CML_I
First Posted: December 18, 2012    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Keywords provided by Dong-A ST Co., Ltd.:
CML
GIST

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Gastrointestinal Stromal Tumors
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action