<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/NCT03005340</url>
  </required_header>
  <id_info>
    <org_study_id>AK-CTR215-I-01</org_study_id>
    <nct_id>NCT03005340</nct_id>
  </id_info>
  <brief_title>A Phase 1 Drug Drug Interaction Clinical Trial of C1-R215 and C2-R215 in Healthy Male Volunteers</brief_title>
  <official_title>A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Coadministration of C1-R215 and C2-R215 Compared to the Administration of C1-R215 and C2-R215 Independently in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alvogen Korea</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alvogen Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, open-label, single-dose, three-treatment, six-sequence, three-way crossover study&#xD;
      to evaluate the safety and pharmacokinetic characteristics after coadministration of C1-R215&#xD;
      and C2-R215 compared to the administration of C1-R215 and C2-R215 independently in healthy&#xD;
      male volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">March 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve(AUCt) of Bazedoxifene</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve(AUCt) of Cholecalciferol</measure>
    <time_frame>-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak plasma concentration(Cmax) of Bazedoxifene</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak plasma concentration(Cmax) of Cholecalciferol</measure>
    <time_frame>-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h</time_frame>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Period 1: Bazedoxifene 20 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Period 1: Bazedoxifene 20 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Cholecalciferol granule 10 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group F</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Cholecalciferol granule 10 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment B</intervention_name>
    <description>Bazedoxifene 20 mg</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_label>Group F</arm_group_label>
    <other_name>Bazedoxifene 20 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment C</intervention_name>
    <description>Cholecalciferol granule 10 mg</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_label>Group F</arm_group_label>
    <other_name>Cholecalciferol granule 10 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment BC</intervention_name>
    <description>Bazedoxifene 20 mg, Cholecalciferol granule 10 mg</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_label>Group F</arm_group_label>
    <other_name>Bazedoxifene 20 mg, Cholecalciferol granule 10 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male between 19 and 45&#xD;
&#xD;
          -  BW is above 50kg and BMI is between 18.5 and 30.0&#xD;
&#xD;
          -  Subject who agreed and signed on informed consent form prior to the study&#xD;
             participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence or history of clinically significant disease&#xD;
&#xD;
          -  Treatment history of any drug which might affect IP within 10days&#xD;
&#xD;
          -  History of other study drugs within 12weeks&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Park</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dong-A University Hospital</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</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>Cholecalciferol</mesh_term>
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Bazedoxifene</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/NCT03005340
org study id: AK-CTR215-I-01
nct id: NCT03005340
lead sponsor: 
has dmc: No
Randomized, open-label, single-dose, three-treatment, six-sequence, three-way crossover study
      to evaluate the safety and pharmacokinetic characteristics after coadministration of C1-R215
      and C2-R215 compared to the administration of C1-R215 and C2-R215 independently in healthy
      male volunteers
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the plasma concentration versus time curve(AUCt) of Bazedoxifene
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h
measure: Area under the plasma concentration versus time curve(AUCt) of Cholecalciferol
time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h
measure: Peak plasma concentration(Cmax) of Bazedoxifene
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h
measure: Peak plasma concentration(Cmax) of Cholecalciferol
time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h
arm group label: Group A
arm group type: Active Comparator
description: Period 1: Bazedoxifene 20 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg
arm group label: Group B
arm group type: Active Comparator
description: Period 1: Bazedoxifene 20 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Cholecalciferol granule 10 mg
arm group label: Group C
arm group type: Active Comparator
description: Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg
arm group label: Group D
arm group type: Active Comparator
description: Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg
arm group label: Group E
arm group type: Active Comparator
description: Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg
arm group label: Group F
arm group type: Active Comparator
description: Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Cholecalciferol granule 10 mg
intervention type: Drug
intervention name: Treatment B
description: Bazedoxifene 20 mg
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
arm group label: Group E
arm group label: Group F
other name: Bazedoxifene 20 mg
intervention type: Drug
intervention name: Treatment C
description: Cholecalciferol granule 10 mg
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
arm group label: Group E
arm group label: Group F
other name: Cholecalciferol granule 10 mg
intervention type: Drug
intervention name: Treatment BC
description: Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
arm group label: Group E
arm group label: Group F
other name: Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Park
role: Principal Investigator
affiliation: Dong-A University Hospital
responsible party type: Sponsor
mesh term: Cholecalciferol
mesh term: Vitamin D
mesh term: Bazedoxifene
sharing ipd: No