<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/NCT03802162</url>
  </required_header>
  <id_info>
    <org_study_id>179BE18029</org_study_id>
    <nct_id>NCT03802162</nct_id>
  </id_info>
  <brief_title>A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355</brief_title>
  <official_title>An Open-label, Randomized, Multiple-dosing Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355 With D797 and D324 in Healthy Subjects</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>
      The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of&#xD;
      CKD-355.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics,&#xD;
      safety and tolerability of CKD-355 with D797 and D324 in healthy subjects&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 10, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax of D324</measure>
    <time_frame>0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours</time_frame>
    <description>Max Concentration of D324</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCt of D324</measure>
    <time_frame>0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours</time_frame>
    <description>Area under the curve of D324</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of D797</measure>
    <time_frame>0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours</time_frame>
    <description>Max Concentration of D797</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCt of D797</measure>
    <time_frame>0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours</time_frame>
    <description>Area under the curve of D797</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmin of D324</measure>
    <time_frame>0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours</time_frame>
    <description>Min Concentration of D324</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin of D797</measure>
    <time_frame>0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours</time_frame>
    <description>Min Concentration of D797</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of D324</measure>
    <time_frame>0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours</time_frame>
    <description>Time of Max concentration of D324</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of D797</measure>
    <time_frame>0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours</time_frame>
    <description>Time of Max concentration of D797</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ of D324</measure>
    <time_frame>0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours</time_frame>
    <description>Half-life time of D324</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ of D797</measure>
    <time_frame>0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours</time_frame>
    <description>Half-life time of D797</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Alzheimer's Disease (AD)</condition>
  <arm_group>
    <arm_group_label>CKD-355A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CKD-355B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>D797, D324</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-355A (D797/Memantine HCl 20mg)</intervention_name>
    <description>once a day</description>
    <arm_group_label>CKD-355A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-355B (D797/Memantine HCl 20mg)</intervention_name>
    <description>once a day</description>
    <arm_group_label>CKD-355B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>D797</intervention_name>
    <description>once a day</description>
    <arm_group_label>D797, D324</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>D324 (Memantine HCl 10mg)</intervention_name>
    <description>twice a day</description>
    <arm_group_label>D797, D324</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adult older than 19 years and less than 55 years at the time of screening&#xD;
&#xD;
          2. BMI 18.5~29.9 kg/m2 and body weight more than 50kg&#xD;
&#xD;
          3. Subjects who have consented to the use of appropriate double- pregnancy contraceptive&#xD;
             methods up to two months after the last investigational product and not to provide&#xD;
             sperm for men&#xD;
&#xD;
          4. Subjects who sign on an informed consent form willingly&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have a clinically significant disease such as respiratory, hepatic,&#xD;
             kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental&#xD;
             disease.&#xD;
&#xD;
          2. Subjects who have acute disease within 28 days prior to the first administration&#xD;
&#xD;
          3. Subjects who have history that may affect the ADME&#xD;
&#xD;
          4. Subjects who have clinically significant chronic disease&#xD;
&#xD;
          5. Women who are nursing, pregnant or positive on pregnancy test&#xD;
&#xD;
          6. Subjects who have clinically significant allergic diseases&#xD;
&#xD;
          7. Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency&#xD;
             or glucose-galactose malabsorption&#xD;
&#xD;
          8. Subjects who are known to be hypersensitive to the drug or its components&#xD;
&#xD;
          9. Subjects who have been found to be positive in serological tests (HBs antigen, HCV&#xD;
             antibody and HIV antibody)&#xD;
&#xD;
         10. Subjects with creatinine clearance &lt;60 ml / min&#xD;
&#xD;
         11. Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range&#xD;
&#xD;
         12. Subjects who taked ETC(Ethical Drug), oriental medicine within 2 weeks and&#xD;
             OTC(Over-the-counter Drug), vitamin within 1 week prior to the first administration&#xD;
&#xD;
         13. Subjects who can not eat standard meals provided by the institution.&#xD;
&#xD;
         14. Subjects who donated whole blood within 60 days, donated the components within 20 days&#xD;
             or received blood within 30 days&#xD;
&#xD;
         15. Subjects who taked medication for the induction and inhibition of metabolizing enzymes&#xD;
             such as barbiturate drugs within 30 days before the first administration&#xD;
&#xD;
         16. Subjects who have had abnormal diets that can affect the ADME of the drug within 30&#xD;
             days before the first administration (eg, ingestion of grapefruit juice&gt;1 L / day)&#xD;
&#xD;
         17. Subjects who participate in the other clinical trial within 90 days prior to the first&#xD;
             administration&#xD;
&#xD;
         18. Subjects who have a history of regular alcohol(alcohol&gt;210g/week) or&#xD;
             caffeine(caffeine&gt;5 cups/day)&#xD;
&#xD;
         19. Subjects who smokes more than 10 cigarettes per day within 3 months or cannot&#xD;
             discontinue smoking during the clinical trial&#xD;
&#xD;
         20. Subjects who is determined unsuitable to participate in this clinical trial by the&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Korea University Anam 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>October 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>October 21, 2019</last_update_submitted>
  <last_update_submitted_qc>October 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's disease</keyword>
  <keyword>CKD-355</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Memantine</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/NCT03802162
org study id: 179BE18029
nct id: NCT03802162
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of
      CKD-355.
An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics,
      safety and tolerability of CKD-355 with D797 and D324 in healthy subjects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax of D324
time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
description: Max Concentration of D324
measure: AUCt of D324
time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
description: Area under the curve of D324
measure: Cmax of D797
time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
description: Max Concentration of D797
measure: AUCt of D797
time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
description: Area under the curve of D797
measure: Cmin of D324
time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
description: Min Concentration of D324
measure: Cmin of D797
time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
description: Min Concentration of D797
measure: Tmax of D324
time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
description: Time of Max concentration of D324
measure: Tmax of D797
time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
description: Time of Max concentration of D797
measure: t½ of D324
time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
description: Half-life time of D324
measure: t½ of D797
time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
description: Half-life time of D797
arm group label: CKD-355A
arm group type: Experimental
arm group label: CKD-355B
arm group type: Experimental
arm group label: D797, D324
arm group type: Active Comparator
intervention type: Drug
intervention name: CKD-355A (D797/Memantine HCl 20mg)
description: once a day
arm group label: CKD-355A
intervention type: Drug
intervention name: CKD-355B (D797/Memantine HCl 20mg)
description: once a day
arm group label: CKD-355B
intervention type: Drug
intervention name: D797
description: once a day
arm group label: D797, D324
intervention type: Drug
intervention name: D324 (Memantine HCl 10mg)
description: twice a day
arm group label: D797, D324
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Memantine