<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/NCT03234244</url>
  </required_header>
  <id_info>
    <org_study_id>HT-008-01</org_study_id>
    <nct_id>NCT03234244</nct_id>
  </id_info>
  <brief_title>HDDO-1614 Intervention Trial</brief_title>
  <official_title>A Randomized, Open-label, Single-dose Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of HDDO-16141 and HDDO-16142 in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hyundai Pharmaceutical Co., LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hyundai Pharmaceutical 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>
      Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2017</start_date>
  <completion_date type="Actual">August 14, 2017</completion_date>
  <primary_completion_date type="Actual">August 14, 2017</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Drug-Drug Interaction</measure>
    <time_frame>Day 1~Day 56</time_frame>
    <description>To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Assessment</measure>
    <time_frame>0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours</time_frame>
    <description>Bazedoxifene Maximum Plasma Concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Assessment</measure>
    <time_frame>0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours</time_frame>
    <description>Bazedoxifene Area Under Curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Assessment</measure>
    <time_frame>Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour</time_frame>
    <description>Maximun Plasma Concentration after correction of basal concentration of Cholecalciferol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Assessment</measure>
    <time_frame>Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour</time_frame>
    <description>Area Under Curve after correction of basal concentration of Cholecalciferol</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Bazedoxifene 20mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will take bazedoxifene 1 Tablet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cholecalciferol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will take Cholecalciferol 2 Tablets.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bazedoxifene 20mg and Cholecalciferol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bazedoxifene 20 mg</intervention_name>
    <description>To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.</description>
    <arm_group_label>Bazedoxifene 20mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol</intervention_name>
    <description>To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.</description>
    <arm_group_label>Cholecalciferol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bazedoxifene 20mg and Cholecalciferol</intervention_name>
    <description>For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.</description>
    <arm_group_label>Bazedoxifene 20mg and Cholecalciferol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body weight 50kg ≤ / BMI=18~29kg/㎡&#xD;
&#xD;
          -  A person who is determined to be eligible for the test through a physical examination&#xD;
             or an interview&#xD;
&#xD;
          -  Those who have been judged to be eligible for the clinical laboratory tests such as&#xD;
             hematology test, blood chemistry test, urine test, urine test, serology test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with clinically significant liver, pancreas, kidney, nervous system,&#xD;
             respiratory, endocrine, hematologic, mental, cardiovascular&#xD;
&#xD;
          -  Patients with a history of gastrointestinal disorders or history of gastrointestinal&#xD;
             surgery that may affect the absorption of pharmaceuticals for clinical trials&#xD;
&#xD;
          -  Any person who shows any of the following results in the screening test&#xD;
&#xD;
               1. AST or ALT &gt; 2 times upper limit of normal range&#xD;
&#xD;
               2. Total Bilirubin &gt; 2.0mg/dL&#xD;
&#xD;
               3. Glomerular filtration rate (eGFR) &lt; 60mL / min/ 1.7㎡&#xD;
&#xD;
          -  Those who show signs of hypotension (systolic blood pressure ≤ 100mmHg or diastolic&#xD;
             blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or&#xD;
             diastolic blood pressure ≥ 95mmHg)&#xD;
&#xD;
          -  Those who have a history of drug abuse or who have a positive urine drug test&#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>Sang-Heon Cho</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inha University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Junggu</city>
        <state>Incheon</state>
        <zip>22332</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>December 8, 2017</last_update_submitted>
  <last_update_submitted_qc>December 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2017</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>Cholecalciferol</mesh_term>
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Bazedoxifene</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/NCT03234244
org study id: HT-008-01
nct id: NCT03234244
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Drug-Drug Interaction
time frame: Day 1~Day 56
description: To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol.
measure: Pharmacokinetic Assessment
time frame: 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
description: Bazedoxifene Maximum Plasma Concentration
measure: Pharmacokinetic Assessment
time frame: 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
description: Bazedoxifene Area Under Curve
measure: Pharmacokinetic Assessment
time frame: Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour
description: Maximun Plasma Concentration after correction of basal concentration of Cholecalciferol
measure: Pharmacokinetic Assessment
time frame: Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour
description: Area Under Curve after correction of basal concentration of Cholecalciferol
arm group label: Bazedoxifene 20mg
arm group type: Active Comparator
description: Subjects will take bazedoxifene 1 Tablet.
arm group label: Cholecalciferol
arm group type: Active Comparator
description: Subjects will take Cholecalciferol 2 Tablets.
arm group label: Bazedoxifene 20mg and Cholecalciferol
arm group type: Experimental
description: Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
intervention type: Drug
intervention name: Bazedoxifene 20 mg
description: To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.
arm group label: Bazedoxifene 20mg
intervention type: Drug
intervention name: Cholecalciferol
description: To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.
arm group label: Cholecalciferol
intervention type: Drug
intervention name: Bazedoxifene 20mg and Cholecalciferol
description: For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
arm group label: Bazedoxifene 20mg and Cholecalciferol
criteria: 
gender: All
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sang-Heon Cho
role: Principal Investigator
affiliation: Inha University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Cholecalciferol
mesh term: Vitamin D
mesh term: Bazedoxifene