<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/NCT04479865</url>
  </required_header>
  <id_info>
    <org_study_id>DA5207_AD_Ib</org_study_id>
    <nct_id>NCT04479865</nct_id>
  </id_info>
  <brief_title>Phase 1 Clinical Trial to Evaluate the Safety, PK and PD of DA-5207 TDS in Healthy Adults</brief_title>
  <official_title>An Open-label, Randomized, Cross-over, Multiple Dose, Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of DA-5207 Transdermal Delivery System in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong-A ST Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dong-A ST Co., Ltd.</source>
  <oversight_info>
    <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 safety, pharmacokinetics and pharmacodynamics of&#xD;
      DA-5207 transdermal delivery system in healthy adults&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 9, 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>AUC</measure>
    <time_frame>29-36 days</time_frame>
    <description>area under the concentration-time curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Css,max</measure>
    <time_frame>0-36 days</time_frame>
    <description>maximum serum concentration at steady state</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aricept 5mg Tablet</intervention_name>
    <description>1 tablet once daily</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aricept 10mg Tablet</intervention_name>
    <description>1 tablet once daily</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA-5207 150mg</intervention_name>
    <description>1 patch once weekly</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA-5207 170mg</intervention_name>
    <description>1 patch once weekly</description>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health Voulunterrs (Age : 19~55 years)&#xD;
&#xD;
          -  Body Weight : Male≥55kg, Female≥50kg&#xD;
&#xD;
          -  18.5 ≤BMI≤ 25.0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption&#xD;
&#xD;
          -  Allergy or Drug hypersensitivity&#xD;
&#xD;
          -  Clinically significant Medical History&#xD;
&#xD;
          -  AST, ALT &gt; Upper Normal Range*1.25, eGFR&lt;60mL/min/1.73m²&#xD;
&#xD;
          -  Heavy alcohol intake (more than 210g/week)&#xD;
&#xD;
          -  Heavy smoker (more than 10 cigarettes/day)&#xD;
&#xD;
          -  Heavy caffeine intake&#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>Severance Hospital Clinical Trial 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>April 2021</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>April 13, 2021</last_update_submitted>
  <last_update_submitted_qc>April 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Donepezil</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/NCT04479865
org study id: DA5207_AD_Ib
nct id: NCT04479865
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of
      DA-5207 transdermal delivery system in healthy adults
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC
time frame: 29-36 days
description: area under the concentration-time curve
measure: Css,max
time frame: 0-36 days
description: maximum serum concentration at steady state
arm group label: Sequence 1
arm group type: Experimental
description: Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg
arm group label: Sequence 2
arm group type: Experimental
description: Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg
arm group label: Sequence 3
arm group type: Experimental
description: Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg
arm group label: Sequence 4
arm group type: Experimental
description: Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg
intervention type: Drug
intervention name: Aricept 5mg Tablet
description: 1 tablet once daily
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
intervention type: Drug
intervention name: Aricept 10mg Tablet
description: 1 tablet once daily
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
intervention type: Drug
intervention name: DA-5207 150mg
description: 1 patch once weekly
arm group label: Sequence 1
arm group label: Sequence 2
intervention type: Drug
intervention name: DA-5207 170mg
description: 1 patch once weekly
arm group label: Sequence 3
arm group label: Sequence 4
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: Donepezil