xml: <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/NCT06010589</url>
    </required_header>
    <id_info>
      <org_study_id>DWJ1558101</org_study_id>
      <nct_id>NCT06010589</nct_id>
    </id_info>
    <brief_title>Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1558 in Healthy Adult Volunteers</brief_title>
    <official_title>Bioequivalence Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1558 and Co-administration of DWC202310 and DWC202311 in Healthy 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>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to compare the pharmacokinetics and safety following administration of&#xD;
        DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy volunteers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 17, 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>Cmax,ss of DWJ1558</measure>
      <time_frame>At pre-dose (0 hour), and post-dose 1 to 72 hour.</time_frame>
      <description>Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1558</description>
    </primary_outcome>
    <primary_outcome>
      <measure>AUCt of DWJ1558</measure>
      <time_frame>At pre-dose (0 hour), and post-dose 1 to 72 hour.</time_frame>
      <description>Area under the curve from the time of dosing to the last measurable concentration(AUCt) of DWJ1558</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">66</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Intervention: DWJ1558</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention: DWC202310 and DWC202311</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DWJ1558</intervention_name>
      <description>DWJ1558</description>
      <arm_group_label>Intervention: DWJ1558</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DWC202310 and DWC202311</intervention_name>
      <description>Co-administration of DWC202310 and DWC202311</description>
      <arm_group_label>Intervention: DWC202310 and DWC202311</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  over 19 year old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pancreatitis&#xD;
  &#xD;
            -  Diabetic ketoacidosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>H Plus YANGJI Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</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>
  
  
text: 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/NCT06010589
  org study id: DWJ1558101
  nct id: NCT06010589
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to compare the pharmacokinetics and safety following administration of
        DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy volunteers.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Cmax,ss of DWJ1558
  time frame: At pre-dose (0 hour), and post-dose 1 to 72 hour.
  description: Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1558
  measure: AUCt of DWJ1558
  time frame: At pre-dose (0 hour), and post-dose 1 to 72 hour.
  description: Area under the curve from the time of dosing to the last measurable concentration(AUCt) of DWJ1558
  arm group label: Intervention: DWJ1558
  arm group type: Experimental
  arm group label: Intervention: DWC202310 and DWC202311
  arm group type: Experimental
  intervention type: Drug
  intervention name: DWJ1558
  description: DWJ1558
  arm group label: Intervention: DWJ1558
  intervention type: Drug
  intervention name: DWC202310 and DWC202311
  description: Co-administration of DWC202310 and DWC202311
  arm group label: Intervention: DWC202310 and DWC202311
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor