Crossover Study to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab in Healthy Male Volunteers

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T (400mg) when administered a single-dose to healthy male volunteers.

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Detailed Description

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Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYO-1126 and Glivec Film Coated tab 4T (400mg) as of imatinib 400mg.

Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYO-1126 and Glivec Film Coated tab 4T (400mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SYO-1126

Imatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)

Group Type EXPERIMENTAL

SYO-1126

Intervention Type DRUG

Imatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)

Glivec film coated tab 4T(400mg)

100mg/tablet, po, 4 tablets once daily for period I\&II D1(crossover)

Group Type ACTIVE_COMPARATOR

Glivec film coated tab 4T(400mg)

Intervention Type DRUG

Imatinib 100mg/tablet, PO, 4 tablets once daily for period I\&II D1(crossover)

Interventions

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SYO-1126

Imatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)

Intervention Type DRUG

Glivec film coated tab 4T(400mg)

Imatinib 100mg/tablet, PO, 4 tablets once daily for period I\&II D1(crossover)

Intervention Type DRUG

Other Intervention Names

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Imatinib 400mg Imatinib 100mg Glivec film coated tab

Eligibility Criteria

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Inclusion Criteria

* Between 20aged and 45aged in healthy males
* Over 55kg and BMI: 18.5\~25 kg/m2
* Agreement with written informed consent

Exclusion Criteria

* Subject with symptoms of acute disease at the time of screening
* Clinically significant cardiovascular system, pulmonary system, renal system, endocrine system, blood system, gastrointestinal system, nervous system, mental disease or malignant tumor
* Subject with known for gastrointestinal disease or surgical history which affect on absorption of drug
* An impossible one who participates in clinical trial by result of screening tests
* Inadequate result of laboratory test AST/ALT \> 1.5 x UNL Total bilirubin \> 1.5 X UNL
* Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
* Subject with known for hypersensitivity reaction to imatinib analog
* Subject with known for history which drug abuse or show positive for it in screening tests
* Previously participate in other trial within 60 days
* Previously make whole blood donation within 60 days or component blood donation within 30 days
* Previously have blood transfusion within 30 days
* Not able to taking the institutional standard meal
* Subject who have had abnormal eating which affect on the ADME of drug
* Not able to taking the grapefruit-containing foods
* Taking ETC(ethical the counter)medicine including oriental medicine within 14 days or taking OTC(over the counter)medicine or vitamin preparations within 7 days
* Continued to be taking caffein(caffein\>5cup/day), drinking (alcohol\>30g/day) and severe heavy smoker(cigarette\>1/2pack/day)
* An impossible one who participates in clinical trial by investigator's decision including for reason laboratory test result

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes