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/NCT05991401</url>
    </required_header>
    <id_info>
      <org_study_id>DA8010_DICR_I</org_study_id>
      <nct_id>NCT05991401</nct_id>
    </id_info>
    <brief_title>Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults</brief_title>
    <official_title>An Open-label, Fixed-sequence, Phase 1 Clinical Trial to Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dong-A ST Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dong-A ST Co., Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of&#xD;
        clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 18, 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>3-period</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Peak Plasma Concentration of DA-8010 (Cmax)</measure>
      <time_frame>0~48hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the plasma concentration versus time curve of DA-8010 (AUClast)</measure>
      <time_frame>0~48hours</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Period 1 or 2 or 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>[Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DA-8010 5mg</intervention_name>
      <description>[Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg</description>
      <arm_group_label>Period 1 or 2 or 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Clarithromycin 500mg</intervention_name>
      <description>[Period 2] DA-8010 5mg, Clarithromycin 500mg</description>
      <arm_group_label>Period 1 or 2 or 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rifampicin 600mg</intervention_name>
      <description>[Period 3] DA-8010 5mg, Rifampicin 600mg</description>
      <arm_group_label>Period 1 or 2 or 3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy adult volunteer 19 years to 50 years&#xD;
  &#xD;
            -  Body weight in the range of 40.0 to 90.0 kg and body mass index in the range of 18 to&#xD;
               28kg/m2&#xD;
  &#xD;
            -  In the case of female volunteers, those who are not necessarily pregnant or lactating&#xD;
               or who are in a surgical infertility condition (both tubular obstruction,&#xD;
               hysterectomy, bilateral tubular resection, etc.)&#xD;
  &#xD;
            -  The subjects personally signed and dated informed consent document after informed of&#xD;
               all patient aspects of the study, fully understanding and determined spontaneously to&#xD;
               participate&#xD;
  &#xD;
            -  The subjects who are judged appropriate to participate this clinical trial according&#xD;
               to the physical examination, routine laboratory examination and questionnaire&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject with serious active hepatobiliary (severe hepatic failure, etc.), renal(severe&#xD;
               renal impairment, etc.), neurologic, immunologic, respiratory, digestive, endocrine,&#xD;
               hematologic, cardiovascular(heart failure, Torsades de pointes, etc), urologic,&#xD;
               psychological disease, sexual disorder, ophthalmologic or history of such disease&#xD;
  &#xD;
            -  Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm,&#xD;
               gastroesophageal reflux disease, Crohn's disease, etc.) or history of such&#xD;
               disease/surgery (excluding simple appendix surgery, hernia surgery, hemorrhoid&#xD;
               surgery)&#xD;
  &#xD;
            -  Subject Hypersensitive to any of the IP components or other drug components(Aspirin,&#xD;
               Antibiotics, etc.)&#xD;
  &#xD;
            -  Subject who is positive for serum test results (hepatitis B test, hepatitis C test,&#xD;
               HIV test, syphilis test)&#xD;
  &#xD;
            -  Subject who have history of drug/alcohol abuse or Positive in Urine drug screen test&#xD;
  &#xD;
            -  Subject who determined that Investigator is unfit to participate in a clinical trial&#xD;
               due to other reasons other than the above items&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Seung Hwan Lee, PhD</last_name>
      <phone>02-2072-2343</phone>
      <email>leejh413@snu.ac.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Seung Hwan Lee, Ph.D</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Clarithromycin</mesh_term>
      <mesh_term>Rifampin</mesh_term>
      <mesh_term>DA-8010</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05991401
  org study id: DA8010_DICR_I
  nct id: NCT05991401
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of
        clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: 3-period
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Peak Plasma Concentration of DA-8010 (Cmax)
  time frame: 0~48hours
  measure: Area under the plasma concentration versus time curve of DA-8010 (AUClast)
  time frame: 0~48hours
  arm group label: Period 1 or 2 or 3
  arm group type: Experimental
  description: [Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg
  intervention type: Drug
  intervention name: DA-8010 5mg
  description: [Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg
  arm group label: Period 1 or 2 or 3
  intervention type: Drug
  intervention name: Clarithromycin 500mg
  description: [Period 2] DA-8010 5mg, Clarithromycin 500mg
  arm group label: Period 1 or 2 or 3
  intervention type: Drug
  intervention name: Rifampicin 600mg
  description: [Period 3] DA-8010 5mg, Rifampicin 600mg
  arm group label: Period 1 or 2 or 3
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Seung Hwan Lee, PhD
  phone: 02-2072-2343
  email: leejh413@snu.ac.kr
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Clarithromycin
  mesh term: Rifampin
  mesh term: DA-8010