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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01751919
First received: December 14, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

  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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dong-A Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751919

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

Publications:

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01751919     History of Changes
Other Study ID Numbers: Imatinib_CML_I
Study First Received: December 14, 2012
Last Updated: December 14, 2012
Health Authority: South Korea : Korea Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 16, 2013