<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/NCT04431141</url>
  </required_header>
  <id_info>
    <org_study_id>MP-C105</org_study_id>
    <nct_id>NCT04431141</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin</brief_title>
  <official_title>A Randomized, Open-label, Multiple-dose, Cross-over Dosing Study to Evaluate Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Handok Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Handok Inc.</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 is to evaluate pharmacokinetic drug interaction between teneligliptin and&#xD;
      empagliflozin in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">January 25, 2021</completion_date>
  <primary_completion_date type="Actual">November 16, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax,ss of teneligliptin and empagliflozin</measure>
    <time_frame>72 hours</time_frame>
    <description>Peak Plasma Concentration (Cmax) at steady state</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCτ,ss of teneligliptin and empagliflozin</measure>
    <time_frame>72 hours</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC) at steady state</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax,ss of teneligliptin and empagliflozin</measure>
    <time_frame>72 hours</time_frame>
    <description>Time to reach Cmax,ss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2β of teneligliptin and empagliflozin</measure>
    <time_frame>72 hours</time_frame>
    <description>Terminal elimination half-life</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Teneligliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Empagliflozin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Teneligliptin and Empagliflozin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teneligliptin</intervention_name>
    <description>Teneligliptin alone</description>
    <arm_group_label>Teneligliptin</arm_group_label>
    <other_name>Tenelia®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin</intervention_name>
    <description>Empagliflozin alone</description>
    <arm_group_label>Empagliflozin</arm_group_label>
    <other_name>Jardiance®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teneligliptin and Empagliflozin</intervention_name>
    <description>Teneligliptin and empagliflozin</description>
    <arm_group_label>Teneligliptin and Empagliflozin</arm_group_label>
    <other_name>Tenelia® and Jardiance®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults between 19 and 45 years of age (both inclusive) at the screening visit&#xD;
&#xD;
          -  Body mass index between 19 kg/m2 and 28 kg/m2 (both inclusive) at the screening visit&#xD;
&#xD;
          -  Subjects must voluntarily decide to participate in the study and provide written&#xD;
             informed consent to comply with study instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of type 1 diabetes mellitus and/or diabetic ketoacidosis&#xD;
&#xD;
          -  Severe infection, surgery, or severe trauma within 6 months prior to the screening&#xD;
             visit&#xD;
&#xD;
          -  Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or&#xD;
             glucose-galactose malabsorption&#xD;
&#xD;
          -  Treatment with any investigational product or study drug in another clinical trial or&#xD;
             bioequivalence study within 180 days prior to the screening visit&#xD;
&#xD;
          -  Any laboratory test or 12-lead ECG finding based on which the subject is determined&#xD;
             ineligible to participate in the study&#xD;
&#xD;
          -  Subject determined by the principal investigator to be ineligible for study conduct&#xD;
             for other reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Pharmacology, Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>November 8, 2021</last_update_submitted>
  <last_update_submitted_qc>November 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Empagliflozin</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/NCT04431141
org study id: MP-C105
nct id: NCT04431141
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate pharmacokinetic drug interaction between teneligliptin and
      empagliflozin in healthy adults.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax,ss of teneligliptin and empagliflozin
time frame: 72 hours
description: Peak Plasma Concentration (Cmax) at steady state
measure: AUCτ,ss of teneligliptin and empagliflozin
time frame: 72 hours
description: Area under the plasma concentration versus time curve (AUC) at steady state
measure: Tmax,ss of teneligliptin and empagliflozin
time frame: 72 hours
description: Time to reach Cmax,ss
measure: t1/2β of teneligliptin and empagliflozin
time frame: 72 hours
description: Terminal elimination half-life
arm group label: Teneligliptin
arm group type: Experimental
arm group label: Empagliflozin
arm group type: Experimental
arm group label: Teneligliptin and Empagliflozin
arm group type: Experimental
intervention type: Drug
intervention name: Teneligliptin
description: Teneligliptin alone
arm group label: Teneligliptin
other name: Tenelia®
intervention type: Drug
intervention name: Empagliflozin
description: Empagliflozin alone
arm group label: Empagliflozin
other name: Jardiance®
intervention type: Drug
intervention name: Teneligliptin and Empagliflozin
description: Teneligliptin and empagliflozin
arm group label: Teneligliptin and Empagliflozin
other name: Tenelia® and Jardiance®
criteria: 
gender: All
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Empagliflozin
sharing ipd: No