<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/NCT03235362</url>
  </required_header>
  <id_info>
    <org_study_id>YH14755-103</org_study_id>
    <nct_id>NCT03235362</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706</brief_title>
  <official_title>A Phase 1, Randomized, Open-label, Multiple-dose, 3-treatment, 6-sequence, 3-period Crossover Clinical Trial to Investigate the Safety and Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuhan Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuhan Corporation</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 is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the&#xD;
      pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, randomized, 6-sequence, 3-period crossover study. Subjects will&#xD;
      receive multiple oral doses of YHR1705, YHR1706 or YHR1705 + YHR1706 QD for 5 consecutive&#xD;
      days. There will be a washout of at least 10 days between the last dose in one period and the&#xD;
      first dose in the subsequent period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">September 19, 2017</completion_date>
  <primary_completion_date type="Actual">September 19, 2017</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>YHR1705, YHR1706 AUCtau</measure>
    <time_frame>0 - 24hours</time_frame>
    <description>AUCtau</description>
  </primary_outcome>
  <primary_outcome>
    <measure>YHR1705, YHR1706 Css, max</measure>
    <time_frame>0 - 24hours</time_frame>
    <description>Css,max</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Dyslipidemia</condition>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1.&#xD;
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 2.&#xD;
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1.&#xD;
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2.&#xD;
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 1.&#xD;
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2.&#xD;
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1.&#xD;
Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 2.&#xD;
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.&#xD;
There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 1.&#xD;
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2.&#xD;
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1.&#xD;
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2.&#xD;
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>YHR1705</intervention_name>
    <description>Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
    <arm_group_label>3</arm_group_label>
    <arm_group_label>4</arm_group_label>
    <arm_group_label>5</arm_group_label>
    <arm_group_label>6</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>YHR1706</intervention_name>
    <description>Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
    <arm_group_label>3</arm_group_label>
    <arm_group_label>4</arm_group_label>
    <arm_group_label>5</arm_group_label>
    <arm_group_label>6</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>YHR1705+YHR1706</intervention_name>
    <description>Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
    <arm_group_label>3</arm_group_label>
    <arm_group_label>4</arm_group_label>
    <arm_group_label>5</arm_group_label>
    <arm_group_label>6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2&#xD;
&#xD;
          -  Who has not suffered from clinically significant disease&#xD;
&#xD;
          -  Provision of signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of and clinically significant disease&#xD;
&#xD;
          -  A history of drug abuse or the presence of positive reactions to drugs that have abuse&#xD;
             potential in urine screenings for drugs&#xD;
&#xD;
          -  Administration of other investigational products within 3 months prior to the first&#xD;
             dosing&#xD;
&#xD;
          -  Volunteers considered not eligible for the clinical trial by the investigator due to&#xD;
             reasons including laboratory test results, ECGs, or vital signs&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Healthy male with body mass index (BMI) between 18.5kg/m2 and 30kg/m2</gender_description>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mingul Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonbuk National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>October 30, 2017</last_update_submitted>
  <last_update_submitted_qc>October 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2017</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>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_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/NCT03235362
org study id: YH14755-103
nct id: NCT03235362
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the
      pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers
This is an open-label, randomized, 6-sequence, 3-period crossover study. Subjects will
      receive multiple oral doses of YHR1705, YHR1706 or YHR1705 + YHR1706 QD for 5 consecutive
      days. There will be a washout of at least 10 days between the last dose in one period and the
      first dose in the subsequent period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: YHR1705, YHR1706 AUCtau
time frame: 0 - 24hours
description: AUCtau
measure: YHR1705, YHR1706 Css, max
time frame: 0 - 24hours
description: Css,max
arm group label: 1
arm group type: Experimental
description: 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.
arm group label: 2
arm group type: Experimental
description: 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.
arm group label: 3
arm group type: Experimental
description: 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.
arm group label: 4
arm group type: Experimental
description: 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.
There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.
arm group label: 5
arm group type: Experimental
description: 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.
arm group label: 6
arm group type: Experimental
description: 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.
intervention type: Drug
intervention name: YHR1705
description: Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.
arm group label: 1
arm group label: 2
arm group label: 3
arm group label: 4
arm group label: 5
arm group label: 6
intervention type: Drug
intervention name: YHR1706
description: Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.
arm group label: 1
arm group label: 2
arm group label: 3
arm group label: 4
arm group label: 5
arm group label: 6
intervention type: Drug
intervention name: YHR1705+YHR1706
description: Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.
arm group label: 1
arm group label: 2
arm group label: 3
arm group label: 4
arm group label: 5
arm group label: 6
criteria: 
gender: Male
gender based: Yes
gender description: Healthy male with body mass index (BMI) between 18.5kg/m2 and 30kg/m2
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mingul Kim, MD
role: Principal Investigator
affiliation: Chonbuk National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Dyslipidemias
sharing ipd: No