<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/NCT04473417</url>
  </required_header>
  <id_info>
    <org_study_id>DA2811_BE_I</org_study_id>
    <nct_id>NCT04473417</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects</brief_title>
  <acronym>DA-2811</acronym>
  <official_title>An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2811 in Healthy Subjects</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>
    <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 the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and Forxiga®&#xD;
      after a single oral dose in healthy volunteers.&#xD;
&#xD;
      The study will also compare the pharmacokinetics and safety profiles of DA-2811 under fasting&#xD;
      and fed states in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2020</start_date>
  <completion_date type="Actual">October 12, 2020</completion_date>
  <primary_completion_date type="Actual">August 26, 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>AUClast</measure>
    <time_frame>pre-dose~48 hours post-dose</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to time the last quantifiable time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>pre-dose~48 hours post-dose</time_frame>
    <description>Maximum plasma concentration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC(0 - ∞)</measure>
    <time_frame>pre-dose~48 hours post-dose</time_frame>
    <description>Area under the plasma concentration versus time curve from time zero to extrapolated infinite time (0 - ∞)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>pre-dose~48 hours post-dose</time_frame>
    <description>Time to reach maximum plasma concentration following drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2</measure>
    <time_frame>pre-dose~48 hours post dose</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Part A, Sequence I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period I: Forxiga® → DA-2811, Period II: DA-2811 → Forxiga®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A, Sequence II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period I: DA-2811 → Forxiga®, Period II: Forxiga® → DA-2811</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B, Sequence I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period I: DA-2811 under fasting state → DA-2811 under fed state, Period II:DA-2811 under fed state → DA-2811 under fasting state</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B, Sequence II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period I: DA-2811 under fed state → DA-2811 under fasting state, Period II: DA-2811 under fasting state → DA-2811 under fed state</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Forxiga</intervention_name>
    <description>single dose administration after 10hr fasting</description>
    <arm_group_label>Part A, Sequence I</arm_group_label>
    <arm_group_label>Part A, Sequence II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA-2811</intervention_name>
    <description>single dose administration after 10hr fasting</description>
    <arm_group_label>Part A, Sequence I</arm_group_label>
    <arm_group_label>Part A, Sequence II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA-2811</intervention_name>
    <description>single dose administration after 10hr fasting</description>
    <arm_group_label>Part B, Sequence I</arm_group_label>
    <arm_group_label>Part B, Sequence II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA-2811</intervention_name>
    <description>single dose administration after high fat and calorie fed diet</description>
    <arm_group_label>Part B, Sequence I</arm_group_label>
    <arm_group_label>Part B, Sequence II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or female subjects&#xD;
&#xD;
          -  BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg&#xD;
&#xD;
          -  Volunteer who totally understands the progress of this clinical trial, make decision&#xD;
             by his or her free will, and signed a consent form to follow the progress.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteer who has present or past history of clinically significant cardiovascular,&#xD;
             respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological,&#xD;
             musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease&#xD;
&#xD;
          -  Vulnerable to dehydration due to poor oral intake or clinically significant&#xD;
             dehydration as judged by the investigator&#xD;
&#xD;
          -  History of gastrointestinal disease or any gastrointestinal surgery(except for simple&#xD;
             appendectomy, hernia surgery, hemorrhoid surgery)&#xD;
&#xD;
          -  History of diseases that may impact absorption, distribution, metabolism, and&#xD;
             excretion of the study drugs.&#xD;
&#xD;
          -  Hypersensitivity to a drug containing an ingredient of the investigational product,&#xD;
             Sodium glucose transporter-2 inhibitors, additional ingredient or other drugs (e.g.,&#xD;
             aspirin, antibiotics, etc.) or medical history of clinically significant&#xD;
             hypersensitivity.&#xD;
&#xD;
          -  History of clinically significant active chronic disease&#xD;
&#xD;
          -  volunteer who has genetic disorder like lapp lactase deficiency or glucose-galactose&#xD;
             malabsorption.&#xD;
&#xD;
          -  History of clinically significant allergies including drug allergies&#xD;
&#xD;
          -  History of drug abuse or addicted&#xD;
&#xD;
          -  Clinical laboratory test values are outside the accepted normal range&#xD;
&#xD;
          -  Participation in another clinical trial within 6 months of the first IP administration&#xD;
&#xD;
          -  Sexually active women of childbearing potential not consistently and correctly&#xD;
             practicing birth control by dual contraceptive method until 2 months after last IP&#xD;
             administration&#xD;
&#xD;
          -  Breast-feeding period, pregnant, or positive to urine pregnancy test (conducted before&#xD;
             the first drug administration)&#xD;
&#xD;
          -  Subjects considered as unsuitable based on medical judgement by investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JaeYong Chung</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bundang Seoul National University Hospital Clinical Trial Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bundangseoul national unversity hospital</name>
      <address>
        <city>Sŏngnam</city>
        <state>GyeonggiDo</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 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>Dapagliflozin</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/NCT04473417
org study id: DA2811_BE_I
nct id: NCT04473417
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and Forxiga®
      after a single oral dose in healthy volunteers.

      The study will also compare the pharmacokinetics and safety profiles of DA-2811 under fasting
      and fed states in healthy subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUClast
time frame: pre-dose~48 hours post-dose
description: Area under the plasma concentration-time curve from time zero to time the last quantifiable time
measure: Cmax
time frame: pre-dose~48 hours post-dose
description: Maximum plasma concentration
measure: AUC(0 - ∞)
time frame: pre-dose~48 hours post-dose
description: Area under the plasma concentration versus time curve from time zero to extrapolated infinite time (0 - ∞)
measure: Tmax
time frame: pre-dose~48 hours post-dose
description: Time to reach maximum plasma concentration following drug administration
measure: t1/2
time frame: pre-dose~48 hours post dose
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
arm group label: Part A, Sequence I
arm group type: Experimental
description: Period I: Forxiga® → DA-2811, Period II: DA-2811 → Forxiga®
arm group label: Part A, Sequence II
arm group type: Experimental
description: Period I: DA-2811 → Forxiga®, Period II: Forxiga® → DA-2811
arm group label: Part B, Sequence I
arm group type: Experimental
description: Period I: DA-2811 under fasting state → DA-2811 under fed state, Period II:DA-2811 under fed state → DA-2811 under fasting state
arm group label: Part B, Sequence II
arm group type: Experimental
description: Period I: DA-2811 under fed state → DA-2811 under fasting state, Period II: DA-2811 under fasting state → DA-2811 under fed state
intervention type: Drug
intervention name: Forxiga
description: single dose administration after 10hr fasting
arm group label: Part A, Sequence I
arm group label: Part A, Sequence II
intervention type: Drug
intervention name: DA-2811
description: single dose administration after 10hr fasting
arm group label: Part A, Sequence I
arm group label: Part A, Sequence II
intervention type: Drug
intervention name: DA-2811
description: single dose administration after 10hr fasting
arm group label: Part B, Sequence I
arm group label: Part B, Sequence II
intervention type: Drug
intervention name: DA-2811
description: single dose administration after high fat and calorie fed diet
arm group label: Part B, Sequence I
arm group label: Part B, Sequence II
criteria: 
gender: All
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: JaeYong Chung
role: Principal Investigator
affiliation: Bundang Seoul National University Hospital Clinical Trial Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dapagliflozin