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

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: SYO-1126 Drug: Glivec film coated tab 4T(400mg)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by Samyang Biopharmaceuticals Corporation:

Primary Outcome Measures:

Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg) [ Time Frame: 0-72hr ] [ Designated as safety issue: No ]
Pharmacokinetics of the Cmax SYO-1126 anf Glivec Film coated tab 4T(400mg) [ Time Frame: 0-72hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics of the AUCinf SYO-1126 and Glivec Film Coated 4T(400mg) [ Time Frame: 0-72hr ] [ Designated as safety issue: No ]
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. [ Time Frame: 20~24 days ] [ Designated as safety issue: No ]
Pharmacokinetics of the Tmax of SYO-1126 and Glivec Film Coated 4T(400mg) [ Time Frame: 0-72hr ] [ Designated as safety issue: No ]
Pharmacokinetics of the T1/2 of SYO-1126 and Glivec Film Coated 4T(400mg) [ Time Frame: 0-72hr ] [ Designated as safety issue: No ]
Pharmacokinetics of the CL/F of SYO-1126 and Glivec Film Coated 4T(400mg) [ Time Frame: 0-72hr ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	March 2012
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SYO-1126 Imatinib 400mg/tablet, PO, 1 tablet once daily for I&II D1(crossover)	Drug: SYO-1126 Imatinib 400mg/tablet, PO, 1 tablet once daily for I&II D1(crossover) Other Names: SYO-1126 Imatinib 400mg
Active Comparator: Glivec film coated tab 4T(400mg) 100mg/tablet, po, 4 tablets once daily for period I&II D1(crossover)	Drug: Glivec film coated tab 4T(400mg) Imatinib 100mg/tablet, PO, 4 tablets once daily for period I&II D1(crossover) Other Names: Imatinib 100mg Glivec film coated tab

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

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504984

Locations

Korea, Republic of
Severance hospital
Seoul, Seodaemun-gu, Korea, Republic of

Sponsors and Collaborators

Samyang Biopharmaceuticals Corporation

Severance Hospital

Investigators

Principal Investigator:

Min Su Park, Doctor

Severance Hospital

More Information

No publications provided

Responsible Party:	Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:	NCT01504984 History of Changes
Other Study ID Numbers:	SYO1126
Study First Received:	December 27, 2011
Last Updated:	June 10, 2012
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samyang Biopharmaceuticals Corporation:

Evaluation of the pharmacokinetics equivalence
Healthy volunteers
Single dose over the period I and II(crossover)
Healthy male volunteers

Additional relevant MeSH terms:

Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013