xml: <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/NCT06025773</url>
    </required_header>
    <id_info>
      <org_study_id>AD-212PK/PD-03</org_study_id>
      <nct_id>NCT06025773</nct_id>
    </id_info>
    <brief_title>A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121</brief_title>
    <official_title>A Randomized, Open-label, 2x2 Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of AD-212-A or AD-2121 in Healthy Adult Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Addpharma Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Addpharma Inc.</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>
        Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic&#xD;
        characteristics of AD-212-A in healthy subjects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic&#xD;
        characteristics and safety profiles of AD-212-A compared with AD-2121 in healthy subjects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 8, 2023</start_date>
    <completion_date type="Anticipated">November 29, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 14, 2023</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>Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)</measure>
      <time_frame>pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)</time_frame>
      <description>AUCτ,ss after 7days repeated administration of Lansoprazole</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percent Decrease from baseline of Integrated gastric acidity</measure>
      <time_frame>24 hours before 1st administration to 24 hours after repeated administration (7days)</time_frame>
      <description>Percent Decrease from baseline of Integrated gastric acidity after repeated adadministration of Lansoprazole&#xD;
  Integrated gastric acidity calculation:&#xD;
  (Integrated gastric acidity Before - Integrated gastric acidity after)/Integrated gastric acidity Before*100&#xD;
  Acid concentration (mM) = 1000 ⅹ 10-pH&#xD;
  Acidity (mmol.h/L) = (acid in mM at time 't' + acid in mM at time 't-1')/2 ⅹ (t-(t-1))&#xD;
  Integrated Acidity means cumulative sum per second for 24 hours</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Gastro Esophageal Reflux</condition>
    <arm_group>
      <arm_group_label>Arm-A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm-B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lansoprazole 15 mg</intervention_name>
      <description>AD-2121 (Lansoprazole 15 mg), Oral, Capsule</description>
      <arm_group_label>Arm-A</arm_group_label>
      <arm_group_label>Arm-B</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lansoprazole 15mg/Calcium carbonate 600mg</intervention_name>
      <description>AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet</description>
      <arm_group_label>Arm-A</arm_group_label>
      <arm_group_label>Arm-B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.5 kg/m2&#xD;
               and 27.0 kg/m2 at the time of screening visit&#xD;
  &#xD;
            -  The Age equal to or greater than 19 in healthy volunteers at the time of screening&#xD;
               visit&#xD;
  &#xD;
            -  Negative result from Serum Helicobacter pylori antibody at the time of screening visit&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with trouble performing Gastric pH monitoring&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jeong Eun Park</last_name>
      <phone>+82-31-891-6989</phone>
      <email>parkje@addpharma.co.kr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Seung Hwan Lee, M.D., Ph.D.</last_name>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</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>Lansoprazole</mesh_term>
      <mesh_term>Dexlansoprazole</mesh_term>
      <mesh_term>Calcium Carbonate</mesh_term>
      <mesh_term>Calcium</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025773
  org study id: AD-212PK/PD-03
  nct id: NCT06025773
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic
        characteristics of AD-212-A in healthy subjects.
  The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic
        characteristics and safety profiles of AD-212-A compared with AD-2121 in healthy subjects.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)
  time frame: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)
  description: AUCτ,ss after 7days repeated administration of Lansoprazole
  measure: Percent Decrease from baseline of Integrated gastric acidity
  time frame: 24 hours before 1st administration to 24 hours after repeated administration (7days)
  description: Percent Decrease from baseline of Integrated gastric acidity after repeated adadministration of Lansoprazole
  Integrated gastric acidity calculation:
  (Integrated gastric acidity Before - Integrated gastric acidity after)/Integrated gastric acidity Before*100
  Acid concentration (mM) = 1000 ⅹ 10-pH
  Acidity (mmol.h/L) = (acid in mM at time 't' + acid in mM at time 't-1')/2 ⅹ (t-(t-1))
  Integrated Acidity means cumulative sum per second for 24 hours
  arm group label: Arm-A
  arm group type: Experimental
  description: Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A)
  arm group label: Arm-B
  arm group type: Experimental
  description: Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121)
  intervention type: Drug
  intervention name: Lansoprazole 15 mg
  description: AD-2121 (Lansoprazole 15 mg), Oral, Capsule
  arm group label: Arm-A
  arm group label: Arm-B
  intervention type: Drug
  intervention name: Lansoprazole 15mg/Calcium carbonate 600mg
  description: AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet
  arm group label: Arm-A
  arm group label: Arm-B
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jeong Eun Park
  phone: +82-31-891-6989
  email: parkje@addpharma.co.kr
  last name: Seung Hwan Lee, M.D., Ph.D.
  responsible party type: Sponsor
  mesh term: Gastroesophageal Reflux
  mesh term: Lansoprazole
  mesh term: Dexlansoprazole
  mesh term: Calcium Carbonate
  mesh term: Calcium