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

NCT01504984 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-06-12

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

SYO-1126

Imatinib 400mg/tablet, PO, 1 tablet once daily for 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)

Sponsors & Collaborators

  • Severance Hospital

    collaborator OTHER

  • Samyang Biopharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Min Su Park, Doctor · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01504984 on ClinicalTrials.gov