Crossover Study to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab in Healthy Male Volunteers
Information source: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: SYO-1126 (Drug); Glivec film coated tab 4T(400mg) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Samyang Biopharmaceuticals Corporation Official(s) and/or principal investigator(s): Min Su Park, Doctor, Principal Investigator, Affiliation: Severance Hospital
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg)Pharmacokinetics of the Cmax SYO-1126 anf Glivec Film coated tab 4T(400mg)
Secondary outcome: Pharmacokinetics of the AUCinf SYO-1126 and Glivec Film Coated 4T(400mg)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. Pharmacokinetics of the Tmax of SYO-1126 and Glivec Film Coated 4T(400mg) Pharmacokinetics of the T1/2 of SYO-1126 and Glivec Film Coated 4T(400mg) Pharmacokinetics of the CL/F of SYO-1126 and Glivec Film Coated 4T(400mg)
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
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
Severance hospital, Seoul, Seodaemun-gu, Korea, Republic of
Additional Information
Starting date: March 2012
Last updated: June 10, 2012
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