<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/NCT03010267</url>
  </required_header>
  <id_info>
    <org_study_id>DP-CTR213-I-04</org_study_id>
    <nct_id>NCT03010267</nct_id>
  </id_info>
  <brief_title>DP-R213 Phase 1 Pharmacokinetics Study</brief_title>
  <official_title>An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Fixed Dose Combination of Raloxifen/Cholecalciferol Compared With Coadministration of Raloxifen and Cholecalciferol in Healthy Male Subjects</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>
      A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics&#xD;
      of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each&#xD;
      component administered alone in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Actual">March 29, 2017</completion_date>
  <primary_completion_date type="Actual">March 8, 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 (AUC)</measure>
    <time_frame>up to 96 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax)</measure>
    <time_frame>up to 96 hours post dose</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>RT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>combination dose of Raloxifene and Cholecaliferol and DP-R213 in order</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TR group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>combination dose of Raloxifene and Cholecaliferol and DP-R213 in order</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DP-R213</intervention_name>
    <description>Investigational product is prescribed to all of randomized subjects</description>
    <arm_group_label>RT group</arm_group_label>
    <arm_group_label>TR group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Raloxifene</intervention_name>
    <description>Investigational product is prescribed to all of randomized subjects</description>
    <arm_group_label>RT group</arm_group_label>
    <arm_group_label>TR group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecaliferol</intervention_name>
    <description>Investigational product is prescribed to all of randomized subjects</description>
    <arm_group_label>RT group</arm_group_label>
    <arm_group_label>TR group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IBW ±20%&#xD;
&#xD;
          -  Signed the informed consent form prior to the study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant disease&#xD;
&#xD;
          -  Previously donate whole blood within 2 months or component blood within 1 month&#xD;
&#xD;
          -  Clinically significant allergic disease&#xD;
&#xD;
          -  Taken IP in other trial within 3 months&#xD;
&#xD;
          -  An impossible one who participates in clinical trial by investigator's decision&#xD;
             including laboratory test result&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>June 1, 2017</last_update_submitted>
  <last_update_submitted_qc>June 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DP-R213</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Raloxifene Hydrochloride</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/NCT03010267
org study id: DP-CTR213-I-04
nct id: NCT03010267
lead sponsor: 
has dmc: No
A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics
      of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each
      component administered alone 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 (AUC)
time frame: up to 96 hours post dose
measure: Peak Plasma Concentration (Cmax)
time frame: up to 96 hours post dose
arm group label: RT group
arm group type: Experimental
description: combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
arm group label: TR group
arm group type: Experimental
description: combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
intervention type: Drug
intervention name: DP-R213
description: Investigational product is prescribed to all of randomized subjects
arm group label: RT group
arm group label: TR group
intervention type: Drug
intervention name: Raloxifene
description: Investigational product is prescribed to all of randomized subjects
arm group label: RT group
arm group label: TR group
intervention type: Drug
intervention name: Cholecaliferol
description: Investigational product is prescribed to all of randomized subjects
arm group label: RT group
arm group label: TR group
criteria: 
gender: Male
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Raloxifene Hydrochloride