<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/NCT03005223</url>
  </required_header>
  <id_info>
    <org_study_id>DW_DWJ1366005</org_study_id>
    <nct_id>NCT03005223</nct_id>
  </id_info>
  <brief_title>Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20163 in Healthy Volunteers</brief_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>
      A randomized, open label, crossover study to explore drug-drug interactions between DWC20155&#xD;
      / DWC20156 and DWC20163 in Healthy Volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 4, 2017</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">May 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Plasma Concentration (Cmax)</measure>
    <time_frame>0 ~ 24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the time versus plasma concentration curve (AUC)</measure>
    <time_frame>0 ~ 24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Study effect of DWC20163 on DWC20155/DWC20156 PK</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To study effect of DWC20163 on DWC20155/DWC20156 PK</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study effect of DWC20155/DWC20156 on DWC20163 PK</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To study effect of DWC20155/DWC20156 on DWC20163 PK</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Co-administration of DWC20155/DWC20156</intervention_name>
    <arm_group_label>Study effect of DWC20155/DWC20156 on DWC20163 PK</arm_group_label>
    <arm_group_label>Study effect of DWC20163 on DWC20155/DWC20156 PK</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWC20163</intervention_name>
    <arm_group_label>Study effect of DWC20155/DWC20156 on DWC20163 PK</arm_group_label>
    <arm_group_label>Study effect of DWC20163 on DWC20155/DWC20156 PK</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Accepts healthy volunteers&#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>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>February 14, 2017</last_update_submitted>
  <last_update_submitted_qc>February 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 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/NCT03005223
org study id: DW_DWJ1366005
nct id: NCT03005223
lead sponsor: 
A randomized, open label, crossover study to explore drug-drug interactions between DWC20155
      / DWC20156 and DWC20163 in Healthy Volunteers
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Plasma Concentration (Cmax)
time frame: 0 ~ 24 hours
measure: Area under the time versus plasma concentration curve (AUC)
time frame: 0 ~ 24 hours
arm group label: Study effect of DWC20163 on DWC20155/DWC20156 PK
arm group type: Experimental
description: To study effect of DWC20163 on DWC20155/DWC20156 PK
arm group label: Study effect of DWC20155/DWC20156 on DWC20163 PK
arm group type: Experimental
description: To study effect of DWC20155/DWC20156 on DWC20163 PK
intervention type: Drug
intervention name: Co-administration of DWC20155/DWC20156
arm group label: Study effect of DWC20155/DWC20156 on DWC20163 PK
arm group label: Study effect of DWC20163 on DWC20155/DWC20156 PK
intervention type: Drug
intervention name: DWC20163
arm group label: Study effect of DWC20155/DWC20156 on DWC20163 PK
arm group label: Study effect of DWC20163 on DWC20155/DWC20156 PK
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor