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

This study has been completed.
Sponsor:
Collaborator:
Severance Hospital
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01504984
First received: December 27, 2011
Last updated: June 10, 2012
Last verified: June 2012
  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:


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 April 22, 2014