<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/NCT03766724</url>
  </required_header>
  <id_info>
    <org_study_id>DA1229_DIS_I</org_study_id>
    <nct_id>NCT03766724</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults</brief_title>
  <official_title>A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg After Oral Administration in Healthy Male 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>
    <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>
      A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic&#xD;
      and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or&#xD;
      Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2018</start_date>
  <completion_date type="Actual">January 18, 2019</completion_date>
  <primary_completion_date type="Actual">January 18, 2019</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUCτ,ss</measure>
    <time_frame>4 weeks</time_frame>
    <description>area under the concentration-time curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax,ss</measure>
    <time_frame>4 weeks</time_frame>
    <description>maximum serum concentration</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evogliptin→Evogliptin+Empagliflozin→Empagliflozin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Empagliflozin→Evogliptin→Evogliptin+Empagliflozin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Evogliptin→Evogliptin+Empagliflozin→Empagliflozin</intervention_name>
    <description>Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD, Empagliflozin : Empagliflozin 25mg QD</description>
    <arm_group_label>Group A</arm_group_label>
    <other_name>Suganon</other_name>
    <other_name>Jardiance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin→Evogliptin→Evogliptin+Empagliflozin</intervention_name>
    <description>Empagliflozin : Empagliflozin 25mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD</description>
    <arm_group_label>Group B</arm_group_label>
    <other_name>Suganon</other_name>
    <other_name>Jardiance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin</intervention_name>
    <description>Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD, Dapagliflozin : Dapagliflozin 10mg QD</description>
    <arm_group_label>Group C</arm_group_label>
    <other_name>Suganon</other_name>
    <other_name>Forxiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin</intervention_name>
    <description>Dapagliflozin : Dapagliflozin 10mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD</description>
    <arm_group_label>Group D</arm_group_label>
    <other_name>Suganon</other_name>
    <other_name>Forxiga</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health Male Volunteers (Age : 19~55 years)&#xD;
&#xD;
          -  Body Weight≥55kg, 18.5≤BMI&lt;25.0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption&#xD;
&#xD;
          -  Allergy or Drug hypersensitivity&#xD;
&#xD;
          -  Clinically significant Medical History&#xD;
&#xD;
          -  AST, ALT &gt; Upper Normal Range*1.25, eGFR&lt;60mL/min/1.73㎡&#xD;
&#xD;
          -  Drink during clinical trial period&#xD;
&#xD;
          -  Smoking during clinical trial period&#xD;
&#xD;
          -  Grapefruit/Caffeine intake during clinical trial period&#xD;
&#xD;
          -  No Contraception&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min soo Park, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Trial Center, Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Trials Center, Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>April 8, 2019</last_update_submitted>
  <last_update_submitted_qc>April 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2019</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>Dapagliflozin</mesh_term>
    <mesh_term>Empagliflozin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03766724
org study id: DA1229_DIS_I
nct id: NCT03766724
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic
      and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or
      Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: AUCτ,ss
time frame: 4 weeks
description: area under the concentration-time curve
measure: Cmax,ss
time frame: 4 weeks
description: maximum serum concentration
arm group label: Group A
arm group type: Experimental
description: Evogliptin→Evogliptin+Empagliflozin→Empagliflozin
arm group label: Group B
arm group type: Experimental
description: Empagliflozin→Evogliptin→Evogliptin+Empagliflozin
arm group label: Group C
arm group type: Experimental
description: Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin
arm group label: Group D
arm group type: Experimental
description: Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin
intervention type: Drug
intervention name: Evogliptin→Evogliptin+Empagliflozin→Empagliflozin
description: Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD, Empagliflozin : Empagliflozin 25mg QD
arm group label: Group A
other name: Suganon
other name: Jardiance
intervention type: Drug
intervention name: Empagliflozin→Evogliptin→Evogliptin+Empagliflozin
description: Empagliflozin : Empagliflozin 25mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD
arm group label: Group B
other name: Suganon
other name: Jardiance
intervention type: Drug
intervention name: Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin
description: Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD, Dapagliflozin : Dapagliflozin 10mg QD
arm group label: Group C
other name: Suganon
other name: Forxiga
intervention type: Drug
intervention name: Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin
description: Dapagliflozin : Dapagliflozin 10mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD
arm group label: Group D
other name: Suganon
other name: Forxiga
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Min soo Park, M.D., Ph.D.
role: Principal Investigator
affiliation: Clinical Trial Center, Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dapagliflozin
mesh term: Empagliflozin