<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/NCT03769870</url>
  </required_header>
  <id_info>
    <org_study_id>MP_C104</org_study_id>
    <nct_id>NCT03769870</nct_id>
  </id_info>
  <brief_title>Teneligliptin and Atorvastatin DDI Study</brief_title>
  <official_title>A Randomized, Open-label, Cross-over, Multiple Dosing Study to Evaluate Drug-drug Interaction Between Teneligliptin and Atorvastatin in Healthy Male 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>
      A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction&#xD;
      between Teneligliptin and Atorvastatin in healthy male adults&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Actual">February 25, 2019</completion_date>
  <primary_completion_date type="Actual">February 25, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax,ss(Maximum concentration at steady state)</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCτ,ss(Area under the concentration-time curve at steady state)</measure>
    <time_frame>24hours</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Diabete Mellitus</condition>
  <arm_group>
    <arm_group_label>Teneligliptin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Teneligliptin + Atorvastatin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teneligliptin 20mg/day</intervention_name>
    <description>cross-over</description>
    <arm_group_label>Teneligliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin 40mg/Day</intervention_name>
    <description>cross-over</description>
    <arm_group_label>Atorvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teneligliptin 20mg/day + Atorvastatin 40mg/day</intervention_name>
    <description>cross-over</description>
    <arm_group_label>Teneligliptin + Atorvastatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male adult 19 to 45 years&#xD;
&#xD;
          2. Body weight ≥ 50kg, and BMI between 18-29kg/m2 at screening&#xD;
&#xD;
          3. Subject who agrees to use a medically acceptable double-barrier method of&#xD;
             contraception and not to donate sperms from the first dose until 2 months after the&#xD;
             last dose.&#xD;
&#xD;
          4. Subject who was given, and fully understood, the information about the study, and has&#xD;
             provided voluntary written informed consent to participate in the study and agreed to&#xD;
             comply with the study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Korea Universitiy Guro 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>May 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>May 28, 2019</last_update_submitted>
  <last_update_submitted_qc>May 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2019</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</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</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/NCT03769870
org study id: MP_C104
nct id: NCT03769870
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction
      between Teneligliptin and Atorvastatin in healthy male adults
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax,ss(Maximum concentration at steady state)
time frame: 24 hours
measure: AUCτ,ss(Area under the concentration-time curve at steady state)
time frame: 24hours
arm group label: Teneligliptin
arm group type: Other
arm group label: Atorvastatin
arm group type: Other
arm group label: Teneligliptin + Atorvastatin
arm group type: Other
intervention type: Drug
intervention name: Teneligliptin 20mg/day
description: cross-over
arm group label: Teneligliptin
intervention type: Drug
intervention name: Atorvastatin 40mg/Day
description: cross-over
arm group label: Atorvastatin
intervention type: Drug
intervention name: Teneligliptin 20mg/day + Atorvastatin 40mg/day
description: cross-over
arm group label: Teneligliptin + Atorvastatin
criteria: 
gender: Male
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
mesh term: Atorvastatin