<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/NCT02223416</url>
  </required_header>
  <id_info>
    <org_study_id>RGB-10-001</org_study_id>
    <nct_id>NCT02223416</nct_id>
  </id_info>
  <brief_title>A Study Aimed at Assessing the Pharmacokinetic Properties of RGB-10 and Forsteo</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gedeon Richter Plc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gedeon Richter Plc.</source>
  <brief_summary>
    <textblock>
      Pharmacokinetic properties, safety and tolerability of RGB-10 and Forsteo will be compared in&#xD;
      healthy female volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC)</measure>
    <time_frame>0-4 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax)</measure>
    <time_frame>0-4 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>RGB-10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Forsteo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RGB-10</intervention_name>
    <arm_group_label>RGB-10</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teriparatide</intervention_name>
    <arm_group_label>Forsteo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult female subjects&#xD;
&#xD;
          -  18-55 years of age (inclusive)&#xD;
&#xD;
          -  BMI must be between 18.5 and 27 kg/m2 (inclusive)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Celerion (UK)</name>
      <address>
        <city>Belfast</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>March 17, 2015</last_update_submitted>
  <last_update_submitted_qc>March 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>female</keyword>
  <keyword>volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Teriparatide</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/NCT02223416
org study id: RGB-10-001
nct id: NCT02223416
lead sponsor: 
Pharmacokinetic properties, safety and tolerability of RGB-10 and Forsteo will be compared in
      healthy female volunteers.
measure: Area under the plasma concentration versus time curve (AUC)
time frame: 0-4 hours
measure: Peak Plasma Concentration (Cmax)
time frame: 0-4 hours
arm group label: RGB-10
arm group type: Experimental
arm group label: Forsteo
arm group type: Active Comparator
intervention type: Drug
intervention name: RGB-10
arm group label: RGB-10
intervention type: Drug
intervention name: Teriparatide
arm group label: Forsteo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Teriparatide