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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: SYO-1126; Drug: Glivec film coated tab 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, Korea, Republic of
      • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg)	0-72hr
Pharmacokinetics of the Cmax SYO-1126 anf Glivec Film coated tab 4T(400mg)	0-72hr

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of the AUCinf SYO-1126 and Glivec Film Coated 4T(400mg)	0-72hr
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.	20~24 days
Pharmacokinetics of the Tmax of SYO-1126 and Glivec Film Coated 4T(400mg)	0-72hr
Pharmacokinetics of the T1/2 of SYO-1126 and Glivec Film Coated 4T(400mg)	0-72hr
Pharmacokinetics of the CL/F of SYO-1126 and Glivec Film Coated 4T(400mg)	0-72hr

Collaborators and Investigators

• Sponsor: Samyang Biopharmaceuticals Corporation
• Collaborators: Severance Hospital
• Investigators: Principal Investigator: Min Su Park, Doctor, Severance Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: December 27, 2011
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (Estimate): January 6, 2012

Study Record Updates

• Last Update Posted (Estimate): June 12, 2012
• Last Update Submitted That Met QC Criteria: June 10, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Healthy volunteers; Healthy male volunteers; Evaluation of the pharmacokinetics equivalence; Single dose over the period I and II(crossover)
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: SYO1126