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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014