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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CJ Imatinib mesylate tablet; Drug: Gleevec film-coated tablet 2 x 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01926548

CJ_IMM_101

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

CJ Imatinib 200mg

Experimental group

Description:

1 tablet(200mg) a day,PO,QD

Treatment:

Drug: CJ Imatinib mesylate tablet

Gleevec 100mg

Active Comparator group

Description:

2 tablet(100mg) a day,PO,QD

Treatment:

Drug: Gleevec film-coated tablet 2 x 100mg