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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01926548

Enrollment

Registered

2013-08-21

Start date

2012-02-29

Completion date

2012-06-30

Last updated

2013-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetics, Safety

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.

Interventions

DRUGCJ Imatinib mesylate tablet

DRUGGleevec film-coated tablet 2 x 100mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
maximum concentration, Area under the concentration-time curve from zero to infinity	Blood sampling up to 72hs post dose(16 times).	Administration of IP : 1day

Secondary

Measure	Time frame	Description
Time to peak concentration, t1/2, Area under the concentration-time curve from zero to infinity	Blood sampling up to 72hs post dose(16 times).	Administration of IP : 1 day

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026