<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/NCT04490434</url>
  </required_header>
  <id_info>
    <org_study_id>DW_DWP14012005</org_study_id>
    <nct_id>NCT04490434</nct_id>
  </id_info>
  <brief_title>Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs</brief_title>
  <official_title>A Randomized, Open-label, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs 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>
  <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>
      drug-drug interaction between DWP14012 and three different kinds of NSAIDs&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between&#xD;
      DWP14012 and three different kinds of NSAIDs in healthy male volunteers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2020</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arm A, Cmax,ss of Celecoxib</measure>
    <time_frame>Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)</time_frame>
    <description>Maximum measured plasma concentration at steady-state</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm A, AUCτ,ss of Celecoxib</measure>
    <time_frame>Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)</time_frame>
    <description>Area under the plasma concentration-time curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm B, Cmax,ss of DWP14012</measure>
    <time_frame>Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)</time_frame>
    <description>Maximum measured plasma concentration at steady-state</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm B, AUCτ,ss of DWP14012</measure>
    <time_frame>Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)</time_frame>
    <description>Area under the plasma concentration-time curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm C, Cmax,ss of Naproxen</measure>
    <time_frame>Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)</time_frame>
    <description>Maximum measured plasma concentration at steady-state</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm C, AUCτ,ss of Naproxen</measure>
    <time_frame>Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)</time_frame>
    <description>Area under the plasma concentration-time curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm D, Cmax,ss of DWP14012</measure>
    <time_frame>Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)</time_frame>
    <description>Maximum measured plasma concentration at steady-state</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm D, AUCτ,ss of DWP14012</measure>
    <time_frame>Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)</time_frame>
    <description>Area under the plasma concentration-time curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm E, Cmax,ss of Meloxicam</measure>
    <time_frame>Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)</time_frame>
    <description>Maximum measured plasma concentration at steady-state</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm E, AUCτ,ss of Meloxicam</measure>
    <time_frame>Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)</time_frame>
    <description>Area under the plasma concentration-time curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm D, Cmax,ss of DWP14012</measure>
    <time_frame>Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)</time_frame>
    <description>Maximum measured plasma concentration at steady-state</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm D, AUCτ,ss of DWP14012</measure>
    <time_frame>Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)</time_frame>
    <description>Area under the plasma concentration-time curve</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Healthy Male Volunteers</condition>
  <arm_group>
    <arm_group_label>Cohort 1, A (DWP14012/Celecoxib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1, B (DWP14012/Celecoxib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2, C (DWP14012/Naproxen)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2, D (DWP14012/Naproxen)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3, E (DWP14012/Meloxicam)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3, F (DWP14012/Meloxicam)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWP14012</intervention_name>
    <description>DWP14012 40mg, bid</description>
    <arm_group_label>Cohort 1, A (DWP14012/Celecoxib)</arm_group_label>
    <arm_group_label>Cohort 1, B (DWP14012/Celecoxib)</arm_group_label>
    <arm_group_label>Cohort 2, C (DWP14012/Naproxen)</arm_group_label>
    <arm_group_label>Cohort 2, D (DWP14012/Naproxen)</arm_group_label>
    <arm_group_label>Cohort 3, E (DWP14012/Meloxicam)</arm_group_label>
    <arm_group_label>Cohort 3, F (DWP14012/Meloxicam)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Celecoxib</intervention_name>
    <description>Celecoxib 200mg, bid</description>
    <arm_group_label>Cohort 1, A (DWP14012/Celecoxib)</arm_group_label>
    <arm_group_label>Cohort 1, B (DWP14012/Celecoxib)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naproxen</intervention_name>
    <description>Naproxen 500mg, bid</description>
    <arm_group_label>Cohort 2, C (DWP14012/Naproxen)</arm_group_label>
    <arm_group_label>Cohort 2, D (DWP14012/Naproxen)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meloxicam</intervention_name>
    <description>Meloxicam 15mg, qd</description>
    <arm_group_label>Cohort 3, E (DWP14012/Meloxicam)</arm_group_label>
    <arm_group_label>Cohort 3, F (DWP14012/Meloxicam)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the&#xD;
             time of screening.&#xD;
&#xD;
          -  Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive)&#xD;
             at screening visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who have clinical significant liver, kidney, nervous system, respiratory,&#xD;
             endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or&#xD;
             past history&#xD;
&#xD;
          -  Those who have gastrointestinal diseases or past history of gastrointestinal diseases&#xD;
             (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's&#xD;
             disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of&#xD;
             study drug, and those who have past history of gastrointestinal surgery (however,&#xD;
             except simple appendectomy and herniotomy)&#xD;
&#xD;
          -  Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of&#xD;
             the normal range in screening including additional examinations prior to randomization&#xD;
&#xD;
          -  Subjects who have participated and taken investigational drug in any other clinical&#xD;
             trial (including bioequivalence study) within six months prior to study drug&#xD;
             administration&#xD;
&#xD;
          -  Subjects who have donated a unit of whole blood within two months or blood components&#xD;
             within one month prior to study drug administration&#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>
  <overall_official>
    <last_name>Jang In-Jin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jang In-Jin, MD, PhD</last_name>
    <phone>+82-2-2072-1910</phone>
    <email>ijjang@snu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>In-Jin Jang, MD, Ph.D</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</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>Celecoxib</mesh_term>
    <mesh_term>Naproxen</mesh_term>
    <mesh_term>Meloxicam</mesh_term>
    <mesh_term>Fexuprazan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04490434
org study id: DW_DWP14012005
nct id: NCT04490434
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
drug-drug interaction between DWP14012 and three different kinds of NSAIDs
to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between
      DWP14012 and three different kinds of NSAIDs in healthy male volunteers
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Arm A, Cmax,ss of Celecoxib
time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
description: Maximum measured plasma concentration at steady-state
measure: Arm A, AUCτ,ss of Celecoxib
time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
description: Area under the plasma concentration-time curve
measure: Arm B, Cmax,ss of DWP14012
time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
description: Maximum measured plasma concentration at steady-state
measure: Arm B, AUCτ,ss of DWP14012
time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
description: Area under the plasma concentration-time curve
measure: Arm C, Cmax,ss of Naproxen
time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
description: Maximum measured plasma concentration at steady-state
measure: Arm C, AUCτ,ss of Naproxen
time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
description: Area under the plasma concentration-time curve
measure: Arm D, Cmax,ss of DWP14012
time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
description: Maximum measured plasma concentration at steady-state
measure: Arm D, AUCτ,ss of DWP14012
time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
description: Area under the plasma concentration-time curve
measure: Arm E, Cmax,ss of Meloxicam
time frame: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)
description: Maximum measured plasma concentration at steady-state
measure: Arm E, AUCτ,ss of Meloxicam
time frame: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)
description: Area under the plasma concentration-time curve
measure: Arm D, Cmax,ss of DWP14012
time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)
description: Maximum measured plasma concentration at steady-state
measure: Arm D, AUCτ,ss of DWP14012
time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)
description: Area under the plasma concentration-time curve
arm group label: Cohort 1, A (DWP14012/Celecoxib)
arm group type: Experimental
description: Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
arm group label: Cohort 1, B (DWP14012/Celecoxib)
arm group type: Experimental
description: Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
arm group label: Cohort 2, C (DWP14012/Naproxen)
arm group type: Experimental
description: Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
arm group label: Cohort 2, D (DWP14012/Naproxen)
arm group type: Experimental
description: Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
arm group label: Cohort 3, E (DWP14012/Meloxicam)
arm group type: Experimental
description: Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.
arm group label: Cohort 3, F (DWP14012/Meloxicam)
arm group type: Experimental
description: Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.
intervention type: Drug
intervention name: DWP14012
description: DWP14012 40mg, bid
arm group label: Cohort 1, A (DWP14012/Celecoxib)
arm group label: Cohort 1, B (DWP14012/Celecoxib)
arm group label: Cohort 2, C (DWP14012/Naproxen)
arm group label: Cohort 2, D (DWP14012/Naproxen)
arm group label: Cohort 3, E (DWP14012/Meloxicam)
arm group label: Cohort 3, F (DWP14012/Meloxicam)
intervention type: Drug
intervention name: Celecoxib
description: Celecoxib 200mg, bid
arm group label: Cohort 1, A (DWP14012/Celecoxib)
arm group label: Cohort 1, B (DWP14012/Celecoxib)
intervention type: Drug
intervention name: Naproxen
description: Naproxen 500mg, bid
arm group label: Cohort 2, C (DWP14012/Naproxen)
arm group label: Cohort 2, D (DWP14012/Naproxen)
intervention type: Drug
intervention name: Meloxicam
description: Meloxicam 15mg, qd
arm group label: Cohort 3, E (DWP14012/Meloxicam)
arm group label: Cohort 3, F (DWP14012/Meloxicam)
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jang In-Jin, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Jang In-Jin, MD, PhD
phone: +82-2-2072-1910
email: ijjang@snu.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Celecoxib
mesh term: Naproxen
mesh term: Meloxicam
mesh term: Fexuprazan
sharing ipd: No