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Completed

NCT Number: NCT01751919

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

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

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumor Gastrointestinal Stromal Tumors Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook National University

Daegu, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imatinib mesylate tablet 400 mg, 1 Tablet

Drug

Glivec film-coated tablet 100 mg, 4 Tablets

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 18, 2012
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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