NCT01504984

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

1 month

First QC Date

December 27, 2011

Last Update Submit

June 10, 2012

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

SYO-1126

EXPERIMENTAL

Imatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)

Drug: SYO-1126

Glivec film coated tab 4T(400mg)

ACTIVE COMPARATOR

100mg/tablet, po, 4 tablets once daily for period I\&II D1(crossover)

Drug: Glivec film coated tab 4T(400mg)

Interventions

SYO-1126DRUG

Imatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)

Also known as: Imatinib 400mg
SYO-1126
Glivec film coated tab 4T(400mg)DRUG

Imatinib 100mg/tablet, PO, 4 tablets once daily for period I\&II D1(crossover)

Also known as: Imatinib 100mg, Glivec film coated tab
Glivec film coated tab 4T(400mg)

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 20aged and 45aged in healthy males
  • Over 55kg and BMI: 18.5\~25 kg/m2
  • Agreement with written informed consent

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, Seodaemun-gu, South Korea

Location

MeSH Terms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Min Su Park, Doctor

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2011

First Posted

January 6, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations

KR(1)