<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/NCT04494243</url>
  </required_header>
  <id_info>
    <org_study_id>AD-214PK/PD</org_study_id>
    <nct_id>NCT04494243</nct_id>
  </id_info>
  <brief_title>A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole</brief_title>
  <official_title>A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Addpharma Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Addpharma Inc.</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>
      A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 10/600mg to&#xD;
      Rabeprazole 10mg in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics&#xD;
      characteristics of AD-214 10/600mg compared with administration of Rabeprazole 10mg in&#xD;
      healthy volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2020</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">January 15, 2021</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>AUCtau,ss(Area under the plasma drug concentration-time curve)</measure>
    <time_frame>From Day 1 up to Day 29</time_frame>
    <description>Evaluateion PK Rabeprazole after multiple dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)</measure>
    <time_frame>Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring</time_frame>
    <description>Evaluation PD Rabeprazole after multiple dose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCtau(Area under the plasma drug concentration-time curve)</measure>
    <time_frame>Day1</time_frame>
    <description>Evaluation PK Rabeprazole after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax(Maximum concentration of drug in plasma)</measure>
    <time_frame>Day1</time_frame>
    <description>Evaluation PK Rabeprazole after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax(Time to maximum plasma concentration)</measure>
    <time_frame>Day1</time_frame>
    <description>Evaluation PK Rabeprazole after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2(Terminal elimination half-life)</measure>
    <time_frame>Day1</time_frame>
    <description>Evaluation PK Rabeprazole after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F(Apparent clearance)</measure>
    <time_frame>Day1</time_frame>
    <description>Evaluation PK Rabeprazole after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vd/F(Apparent volume of distribution)</measure>
    <time_frame>Day1</time_frame>
    <description>Evaluation PK Rabeprazole after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss(Maximum concentration of drug in plasma at steady state)</measure>
    <time_frame>From Day 1 up to Day 29</time_frame>
    <description>Evaluation PK Rabeprazole after multiple dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)</measure>
    <time_frame>From Day 1 up to Day 29</time_frame>
    <description>Evaluation PK Rabeprazole after multiple dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cav,ss(Average concentration of drug in plasma at steady state)</measure>
    <time_frame>From Day 1 up to Day 29</time_frame>
    <description>Evaluation PK Rabeprazole after multiple dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax,ss(Time to maximum plasma concentration at steady state)</measure>
    <time_frame>From Day 1 up to Day 29</time_frame>
    <description>Evaluation PK Rabeprazole after multiple dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2,ss(Terminal elimination half-life at steady state)</measure>
    <time_frame>From Day 1 up to Day 29</time_frame>
    <description>Evaluation PK Rabeprazole after multiple dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLss/F(Apparent Clearance at steady state)</measure>
    <time_frame>From Day 1 up to Day 29</time_frame>
    <description>Evaluation PK Rabeprazole after multiple dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vss/F(Apparent Volume of distribution at steady state)</measure>
    <time_frame>From Day 1 up to Day 29</time_frame>
    <description>Evaluation PK Rabeprazole after multiple dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTF(Peak trough fluctuation over one dosing interal at steady state)</measure>
    <time_frame>From Day 1 up to Day 29</time_frame>
    <description>Evaluation PK Rabeprazole after multiple dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours</measure>
    <time_frame>Day1 24hours monitoring</time_frame>
    <description>Evaluation PD Rabeoprazoke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours</measure>
    <time_frame>Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring</time_frame>
    <description>Evaluation PD Rabeoprazoke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>After the first administration and 7 days of repeated administration, The median pH measured for 24 hours</measure>
    <time_frame>Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring</time_frame>
    <description>Evaluation PD Rabeoprazoke</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>AD-214/Rabeprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 : Test Drug(AD-214 10/600mg) Period 2 : Reference Drug(Rabeprazole 10mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rabeprazole/AD-214</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 : Reference Drug(Rabeprazole 10mg) Period 2 : Test Drug(AD-214 10/600mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AD-214 10/600mg</intervention_name>
    <description>1 tablet administered before the breakfast during 7 days</description>
    <arm_group_label>AD-214/Rabeprazole</arm_group_label>
    <arm_group_label>Rabeprazole/AD-214</arm_group_label>
    <other_name>Test drug</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rabeprazole 10mg</intervention_name>
    <description>1 tablet administered before the breakfast during 7 days</description>
    <arm_group_label>AD-214/Rabeprazole</arm_group_label>
    <arm_group_label>Rabeprazole/AD-214</arm_group_label>
    <other_name>Reference Drug</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 19~50 years in healthy volunteers&#xD;
&#xD;
          -  BMI is more than 18.0 kg/m^2 , no more than 27.0 kg/m^2&#xD;
&#xD;
          -  Subjects who have ability to comprehend the objectives, contents of study and property&#xD;
             of study drug before participating in trial and have willingness to sign of informed&#xD;
             consent in writing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of medical history or a concurrent disease that may interfere with treatment&#xD;
             and safety assessment or completion of this clinical study, including clinically&#xD;
             significant disorders in digestive system, neuropsychiatric system, endocrine system,&#xD;
             liver, cardiovascular system&#xD;
&#xD;
          -  Subjects who judged ineligible by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seunghwan Lee, M.D.,Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University 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>July 2021</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</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>Gastroesophageal Reflux</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rabeprazole</mesh_term>
  </intervention_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/NCT04494243
org study id: AD-214PK/PD
nct id: NCT04494243
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 10/600mg to
      Rabeprazole 10mg in healthy volunteers.
This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics
      characteristics of AD-214 10/600mg compared with administration of Rabeprazole 10mg in
      healthy volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUCtau,ss(Area under the plasma drug concentration-time curve)
time frame: From Day 1 up to Day 29
description: Evaluateion PK Rabeprazole after multiple dose
measure: Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)
time frame: Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
description: Evaluation PD Rabeprazole after multiple dose
measure: AUCtau(Area under the plasma drug concentration-time curve)
time frame: Day1
description: Evaluation PK Rabeprazole after single dose
measure: Cmax(Maximum concentration of drug in plasma)
time frame: Day1
description: Evaluation PK Rabeprazole after single dose
measure: Tmax(Time to maximum plasma concentration)
time frame: Day1
description: Evaluation PK Rabeprazole after single dose
measure: t1/2(Terminal elimination half-life)
time frame: Day1
description: Evaluation PK Rabeprazole after single dose
measure: CL/F(Apparent clearance)
time frame: Day1
description: Evaluation PK Rabeprazole after single dose
measure: Vd/F(Apparent volume of distribution)
time frame: Day1
description: Evaluation PK Rabeprazole after single dose
measure: Cmax,ss(Maximum concentration of drug in plasma at steady state)
time frame: From Day 1 up to Day 29
description: Evaluation PK Rabeprazole after multiple dose
measure: Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)
time frame: From Day 1 up to Day 29
description: Evaluation PK Rabeprazole after multiple dose
measure: Cav,ss(Average concentration of drug in plasma at steady state)
time frame: From Day 1 up to Day 29
description: Evaluation PK Rabeprazole after multiple dose
measure: Tmax,ss(Time to maximum plasma concentration at steady state)
time frame: From Day 1 up to Day 29
description: Evaluation PK Rabeprazole after multiple dose
measure: t1/2,ss(Terminal elimination half-life at steady state)
time frame: From Day 1 up to Day 29
description: Evaluation PK Rabeprazole after multiple dose
measure: CLss/F(Apparent Clearance at steady state)
time frame: From Day 1 up to Day 29
description: Evaluation PK Rabeprazole after multiple dose
measure: Vss/F(Apparent Volume of distribution at steady state)
time frame: From Day 1 up to Day 29
description: Evaluation PK Rabeprazole after multiple dose
measure: PTF(Peak trough fluctuation over one dosing interal at steady state)
time frame: From Day 1 up to Day 29
description: Evaluation PK Rabeprazole after multiple dose
measure: After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours
time frame: Day1 24hours monitoring
description: Evaluation PD Rabeoprazoke
measure: After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours
time frame: Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
description: Evaluation PD Rabeoprazoke
measure: After the first administration and 7 days of repeated administration, The median pH measured for 24 hours
time frame: Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
description: Evaluation PD Rabeoprazoke
arm group label: AD-214/Rabeprazole
arm group type: Experimental
description: Period 1 : Test Drug(AD-214 10/600mg) Period 2 : Reference Drug(Rabeprazole 10mg)
arm group label: Rabeprazole/AD-214
arm group type: Experimental
description: Period 1 : Reference Drug(Rabeprazole 10mg) Period 2 : Test Drug(AD-214 10/600mg)
intervention type: Drug
intervention name: AD-214 10/600mg
description: 1 tablet administered before the breakfast during 7 days
arm group label: AD-214/Rabeprazole
arm group label: Rabeprazole/AD-214
other name: Test drug
intervention type: Drug
intervention name: Rabeprazole 10mg
description: 1 tablet administered before the breakfast during 7 days
arm group label: AD-214/Rabeprazole
arm group label: Rabeprazole/AD-214
other name: Reference Drug
criteria: 
gender: All
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Seunghwan Lee, M.D.,Ph.D
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Rabeprazole
sharing ipd: No