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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

NCT ID: NCT01926548

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Pharmacokinetics Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CJ Imatinib 200mg

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

Group Type EXPERIMENTAL

CJ Imatinib mesylate tablet

Intervention Type DRUG

Gleevec 100mg

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

Group Type ACTIVE_COMPARATOR

Gleevec film-coated tablet 2 x 100mg

Intervention Type DRUG

Interventions

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CJ Imatinib mesylate tablet

Intervention Type DRUG

Gleevec film-coated tablet 2 x 100mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CJ_IMM_101

Identifier Type: -

Identifier Source: org_study_id