Clinical trial NCT01504984: Crossover Study to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab in Healthy Male Volunteers
Official title: An Open-label, Randomized, Single Dose, Crossover Phase I Clinical Trial to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab., 4T (400mg) in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Evaluation of the pharmacokinetics equivalence
Healthy volunteers
Single dose over the period I and II(crossover)
Healthy male volunteers
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
Collaborators: name: Severance Hospital
First posted: 2012-01-06
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg)
timeFrame: 0-72hr
measure: Pharmacokinetics of the Cmax SYO-1126 anf Glivec Film coated tab 4T(400mg)
timeFrame: 0-72hr
Secondary outcomes:
measure: Pharmacokinetics of the AUCinf SYO-1126 and Glivec Film Coated 4T(400mg)
timeFrame: 0-72hr
measure: Evaluation of the safety of SYO-1126 and Glivec Film Coated 4T(400mg) from vital signs, physical exam, ECG, laboratory test, adverse events and so on.
timeFrame: 20~24 days
measure: Pharmacokinetics of the Tmax of SYO-1126 and Glivec Film Coated 4T(400mg)
timeFrame: 0-72hr
measure: Pharmacokinetics of the T1/2 of SYO-1126 and Glivec Film Coated 4T(400mg)
timeFrame: 0-72hr
measure: Pharmacokinetics of the CL/F of SYO-1126 and Glivec Film Coated 4T(400mg)
timeFrame: 0-72hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
state: Seodaemun-gu
Study officials:
affiliation: Severance Hospital
name: Min Su Park, Doctor
role: PRINCIPAL_INVESTIGATOR
References: