<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/NCT03016520</url>
  </required_header>
  <id_info>
    <org_study_id>DW_DWJ1392001</org_study_id>
    <nct_id>NCT03016520</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Safety Study of DWJ1392 and DWC20164 in Healthy Male Volunteers</brief_title>
  <official_title>An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics and Safety of DWJ1392 and DWC20164 in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daewoong Pharmaceutical Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daewoong Pharmaceutical Co. LTD.</source>
  <brief_summary>
    <textblock>
      The purpose of this study to Compare the safety and pharmacokinetics of DWJ1392 and DWC20164&#xD;
      in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Actual">January 26, 2017</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Plasma Concentration (Cmax)</measure>
    <time_frame>0-72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC)</measure>
    <time_frame>0-72 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Test drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DWJ1392</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DWC20164</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWJ1392</intervention_name>
    <arm_group_label>Test drug</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWC20164</intervention_name>
    <arm_group_label>Reference drug</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No clinically significant findings&#xD;
&#xD;
          -  Age 19-50 years at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Who has allergy to investigational product&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul ST. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Han Seunghoon</last_name>
      <phone>82-2-2258-7877</phone>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>February 6, 2017</last_update_submitted>
  <last_update_submitted_qc>February 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03016520
org study id: DW_DWJ1392001
nct id: NCT03016520
lead sponsor: 
The purpose of this study to Compare the safety and pharmacokinetics of DWJ1392 and DWC20164
      in healthy male volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Maximum Plasma Concentration (Cmax)
time frame: 0-72 hours
measure: Area under the plasma concentration versus time curve (AUC)
time frame: 0-72 hours
arm group label: Test drug
arm group type: Experimental
description: DWJ1392
arm group label: Reference drug
arm group type: Experimental
description: DWC20164
intervention type: Drug
intervention name: DWJ1392
arm group label: Test drug
intervention type: Drug
intervention name: DWC20164
arm group label: Reference drug
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor