<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/NCT03764462</url>
  </required_header>
  <id_info>
    <org_study_id>AD-101BE</org_study_id>
    <nct_id>NCT03764462</nct_id>
  </id_info>
  <brief_title>Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers</brief_title>
  <official_title>A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 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>
    <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 pharmacokinetic characteristics of AD-101 in&#xD;
      healthy volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared&#xD;
      with administration of raloxifen 60 mg in healthy adults&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Actual">February 8, 2019</completion_date>
  <primary_completion_date type="Actual">January 2, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax)</measure>
    <time_frame>pre-dose to 96 hours</time_frame>
    <description>Cmax of the total ingredient of AD-101</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the curve in time plot (AUCt)</measure>
    <time_frame>pre-dose to 96 hours</time_frame>
    <description>AUCt of the total ingredient of AD-101</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the curve in time plot (AUCinf)</measure>
    <time_frame>pre-dose to 96 hours</time_frame>
    <description>AUCinf of the total ingredient of AD-101</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach Cmax</measure>
    <time_frame>pre-dose to 96 hours</time_frame>
    <description>Tmax of the total ingredient of AD-101</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effective half-life</measure>
    <time_frame>pre-dose to 96 hours</time_frame>
    <description>t1/2 of the total ingredient of AD-101</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance</measure>
    <time_frame>pre-dose to 96 hours</time_frame>
    <description>CL/F of the total ingredient of AD-101</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution</measure>
    <time_frame>pre-dose to 96 hours</time_frame>
    <description>Vd/F of the total ingredient of AD-101</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>From Day 1 until 40 Days</time_frame>
    <description>Incidence rate of adverse events</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Raloxifene 60mg to AD-101 45mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AD-101 45mg to Raloxifene 60mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AD-101 45mg</intervention_name>
    <description>Raloxifene 45mg tablet</description>
    <arm_group_label>AD-101 45mg to Raloxifene 60mg</arm_group_label>
    <arm_group_label>Raloxifene 60mg to AD-101 45mg</arm_group_label>
    <other_name>AD-101</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Raloxifene 60mg</intervention_name>
    <description>Raloxifene 60mg tablet</description>
    <arm_group_label>AD-101 45mg to Raloxifene 60mg</arm_group_label>
    <arm_group_label>Raloxifene 60mg to AD-101 45mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Adult aged 19 and more at the time of screening visit&#xD;
&#xD;
          -  Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit&#xD;
&#xD;
          -  No evidence of medical symptoms or signs of congenital or no chronic disease within&#xD;
             the last 3 years as a result of medical examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of clinically significant blood, kidney, endocrine, respiratory,&#xD;
             gastrointestinal, urinary, cardiovascular, liver, nerve or allergic disease (except&#xD;
             for asymptomatic seasonal allergy untreated at the time of administration)&#xD;
&#xD;
          -  History of gastrointestinal disorders (esophageal ataxia or esophageal strictures,&#xD;
             Crohn's disease, etc.) or surgery (excluding simple cecal surgery or hernia surgery)&#xD;
             that may affect the absorption of drugs&#xD;
&#xD;
          -  As a result of laboratory tests, the following figures: ALT or AST&gt; 2 times upper&#xD;
             limit of normal range&#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_official>
    <last_name>Young-Ran Yoon, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyungpook National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>August 29, 2019</last_update_submitted>
  <last_update_submitted_qc>August 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2019</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>Osteoporosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Raloxifene Hydrochloride</mesh_term>
    <mesh_term>AD 101</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/NCT03764462
org study id: AD-101BE
nct id: NCT03764462
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in
      healthy volunteers
This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared
      with administration of raloxifen 60 mg in healthy adults
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax)
time frame: pre-dose to 96 hours
description: Cmax of the total ingredient of AD-101
measure: Area under the curve in time plot (AUCt)
time frame: pre-dose to 96 hours
description: AUCt of the total ingredient of AD-101
measure: Area under the curve in time plot (AUCinf)
time frame: pre-dose to 96 hours
description: AUCinf of the total ingredient of AD-101
measure: Time to reach Cmax
time frame: pre-dose to 96 hours
description: Tmax of the total ingredient of AD-101
measure: Effective half-life
time frame: pre-dose to 96 hours
description: t1/2 of the total ingredient of AD-101
measure: Clearance
time frame: pre-dose to 96 hours
description: CL/F of the total ingredient of AD-101
measure: Volume of distribution
time frame: pre-dose to 96 hours
description: Vd/F of the total ingredient of AD-101
measure: Number of participants with adverse events
time frame: From Day 1 until 40 Days
description: Incidence rate of adverse events
arm group label: Raloxifene 60mg to AD-101 45mg
arm group type: Experimental
description: Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral
arm group label: AD-101 45mg to Raloxifene 60mg
arm group type: Experimental
description: Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral
intervention type: Drug
intervention name: AD-101 45mg
description: Raloxifene 45mg tablet
arm group label: AD-101 45mg to Raloxifene 60mg
arm group label: Raloxifene 60mg to AD-101 45mg
other name: AD-101
intervention type: Drug
intervention name: Raloxifene 60mg
description: Raloxifene 60mg tablet
arm group label: AD-101 45mg to Raloxifene 60mg
arm group label: Raloxifene 60mg to AD-101 45mg
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Young-Ran Yoon, M.D., Ph.D
role: Principal Investigator
affiliation: Kyungpook National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Raloxifene Hydrochloride
mesh term: AD 101
sharing ipd: No