<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/NCT03793985</url>
  </required_header>
  <id_info>
    <org_study_id>152BE17006</org_study_id>
    <nct_id>NCT03793985</nct_id>
  </id_info>
  <brief_title>Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337</brief_title>
  <official_title>Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337 in Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</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>
      Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337&#xD;
      combination&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2018</start_date>
  <completion_date type="Actual">November 13, 2018</completion_date>
  <primary_completion_date type="Actual">October 23, 2018</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</measure>
    <time_frame>0~72hours</time_frame>
    <description>To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCt</measure>
    <time_frame>0~72hours</time_frame>
    <description>To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Hyperlipidemias</condition>
  <arm_group>
    <arm_group_label>A (R+T+R+T)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 : R Period 2 : T Period 3 : R Period 4 : T</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B (T+R+T+R)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Period 1 : T Period 2 : R Period 3 : T Period 4 : R</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>T</intervention_name>
    <description>CKD-391 40/10mg</description>
    <arm_group_label>A (R+T+R+T)</arm_group_label>
    <arm_group_label>B (T+R+T+R)</arm_group_label>
    <other_name>Test Drug</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>R</intervention_name>
    <description>D086 and D337 co-administration</description>
    <arm_group_label>A (R+T+R+T)</arm_group_label>
    <arm_group_label>B (T+R+T+R)</arm_group_label>
    <other_name>Reference drug</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 19 aged and 45 aged in healthy male adult&#xD;
&#xD;
          2. Over 50 kg, BMI between 18.0-29.0 kg/m2&#xD;
&#xD;
          3. Subjects in good health as determined by physical exams and medical examinations. No&#xD;
             congenital or chronic diseases and no abnormal signs determined by medical&#xD;
             examinations.&#xD;
&#xD;
          4. Not abnormal or not clinically significant lab values.&#xD;
&#xD;
          5. Subjects who signed informed consent form with good understandings after explanations&#xD;
             by investigators.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No history or presence of clinically significant diseases.&#xD;
&#xD;
          2. Subjects showing adverse reaction to investigational product&#xD;
&#xD;
          3. Genetic problems in galactose intolerance, Lapp lactose deficiency, or&#xD;
             glucose-galactose malabsorption.&#xD;
&#xD;
          4. History of myopathy&#xD;
&#xD;
          5. Subjects with abnormal lab values at least one below 1) AST or ALT&gt;2 fold of upper&#xD;
             normal limit 2) Total bilirubin&gt;2 fold of upper normal limit 3) CK&gt;2 fold of upper&#xD;
             normal limit 4) Estimated Glomerular filtration rate&lt;60mL/min/1.73m2&#xD;
&#xD;
          6. Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop&#xD;
             drinking during clinical trials&#xD;
&#xD;
          7. Smoke over 10 cigarettes per day or unable to stop smoking&#xD;
&#xD;
          8. Subjects who previously participated in other clinical trials within 90 days&#xD;
&#xD;
          9. Subjects who donated whole blood within 60 days or donated component blood within 30&#xD;
             days or received blood transfusion within 30 days&#xD;
&#xD;
         10. Subjects who took any prescribed medications or oriental medicines within 14 days, or&#xD;
             took any pharmacy medicines within 10 days.&#xD;
&#xD;
         11. Taking medications which induce or block medication metabolism&#xD;
&#xD;
         12. History of drug abuse&#xD;
&#xD;
         13. Subjects who took any prescribed medications or oriental medicines within 14 days, or&#xD;
             took any pharmacy medicines within 7 days.&#xD;
&#xD;
         14. Disagree to contraception&#xD;
&#xD;
         15. Subjects who are in any conditions impossible participating in the clinical trials&#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>INHA University Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 4, 2019</last_update_submitted>
  <last_update_submitted_qc>January 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 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>Hyperlipidemias</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/NCT03793985
org study id: 152BE17006
nct id: NCT03793985
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337
      combination
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax
time frame: 0~72hours
description: To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax
measure: AUCt
time frame: 0~72hours
description: To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt
arm group label: A (R+T+R+T)
arm group type: Experimental
description: Period 1 : R Period 2 : T Period 3 : R Period 4 : T
arm group label: B (T+R+T+R)
arm group type: Active Comparator
description: Period 1 : T Period 2 : R Period 3 : T Period 4 : R
intervention type: Drug
intervention name: T
description: CKD-391 40/10mg
arm group label: A (R+T+R+T)
arm group label: B (T+R+T+R)
other name: Test Drug
intervention type: Drug
intervention name: R
description: D086 and D337 co-administration
arm group label: A (R+T+R+T)
arm group label: B (T+R+T+R)
other name: Reference drug
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: Hyperlipidemias
sharing ipd: No