<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01725620</url>
  </required_header>
  <id_info>
    <org_study_id>LG-ECCL003</org_study_id>
    <nct_id>NCT01725620</nct_id>
  </id_info>
  <brief_title>Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25mg With Those of Enbrel®</brief_title>
  <official_title>A Randomized, Double-blind, Single-dosing, 2-way Cross-over Study to Compate the Safety and Pharmacokinetic Characteristics of LBEC0101(Etanercept) 25mg With Those of Enbrel® 25mg After Subcutaneous Injection in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LG Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LG Life Sciences</source>
  <brief_summary>
    <textblock>
      To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator,&#xD;
      Enbrel® 25mg.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enbrel, LBEC0101</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LBEC0101, Enbrel</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LBEC0101 (Etanercept 25mg)</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enbrel (Etanercept 25mg)</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males, 20 to 45 years of age the moment of screening&#xD;
&#xD;
          -  Body mass index is between 18.0 and 30.0 kg/m&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The tuberculosis patient of latent tuberculosis patient&#xD;
&#xD;
          -  Hypersensitivity response to the test and comparator drugs&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyung-Sang Yu, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University College of Medicine and Hospitaal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital, Clinical Trial Center</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>January 29, 2015</last_update_submitted>
  <last_update_submitted_qc>January 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etanercept</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01725620
org study id: LG-ECCL003
nct id: NCT01725620
lead sponsor: 
To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator,
      Enbrel® 25mg.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
arm group label: Group 1
arm group type: Experimental
description: Enbrel, LBEC0101
arm group label: Group 2
arm group type: Experimental
description: LBEC0101, Enbrel
intervention type: Drug
intervention name: LBEC0101 (Etanercept 25mg)
arm group label: Group 1
arm group label: Group 2
intervention type: Drug
intervention name: Enbrel (Etanercept 25mg)
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kyung-Sang Yu, M.D., Ph.D.
role: Principal Investigator
affiliation: Seoul National University College of Medicine and Hospitaal
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Etanercept