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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

Page last updated: August 23, 2015

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