Status:
COMPLETED
Crossover Study to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab in Healthy Male Volunteers
Lead Sponsor:
Samyang Biopharmaceuticals Corporation
Collaborating Sponsors:
Severance Hospital
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
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 admin...
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 medicati...
Eligibility Criteria
Inclusion
- Between 20aged and 45aged in healthy males
- Over 55kg and BMI: 18.5\~25 kg/m2
- Agreement with written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01504984
Start Date
March 1 2012
End Date
April 1 2012
Last Update
June 12 2012
Active Locations (1)
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1
Severance hospital
Seoul, Seodaemun-gu, South Korea