<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/NCT01676571</url>
  </required_header>
  <id_info>
    <org_study_id>14077A</org_study_id>
    <nct_id>NCT01676571</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Properties of Lu AA21004 (Vortioxetine) in Healthy Young Chinese Men and Women</brief_title>
  <official_title>A Single-centre, Open-label, Single-dose Interventional Study Investigating the Pharmacokinetic Properties of Lu AA21004 in Healthy Young Chinese Men and Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lundbeck A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu&#xD;
      AA21004 (Vortioxetine) in the Chinese population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PK AUC determination of Lu AA21004 (Vortioxetine)</measure>
    <time_frame>11 days</time_frame>
    <description>Area under the curve (AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK Cmax determination of Lu AA21004 (Vortioxetine)</measure>
    <time_frame>11 days</time_frame>
    <description>Maximum observed concentration (Cmax)</description>
  </primary_outcome>
  <other_outcome>
    <measure>PK MR determination of metabolites Lu AA34443 and Lu AA39835</measure>
    <time_frame>11 days</time_frame>
    <description>Metabolic ratio (MR)</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of patients with adverse events as a measure of safety and tolerability</measure>
    <time_frame>11 days</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Lu AA21004</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lu AA21004</intervention_name>
    <description>10 mg immediate-release (IR), one single dose, orally</description>
    <arm_group_label>Lu AA21004</arm_group_label>
    <other_name>Vortioxetine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject is a Chinese man or woman&#xD;
&#xD;
          -  The subject is, in the opinion of the investigator, generally healthy&#xD;
&#xD;
          -  If female, the subject must have a negative pregnancy test at screening and baseline,&#xD;
             and agree not to try to become pregnant from Screening until after the Follow-up Visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is, in the opinion of the investigator, unlikely to comply with the&#xD;
             clinical study protocol or is unsuitable for any other reason.&#xD;
&#xD;
        Other inclusion and exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Email contact via H. Lundbeck A/S</last_name>
    <role>Study Director</role>
    <affiliation>LundbeckClinicalTrials@lundbeck.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CN001</name>
      <address>
        <city>Tianjin</city>
        <zip>300457</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>January 15, 2013</last_update_submitted>
  <last_update_submitted_qc>January 15, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2013</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>Vortioxetine</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/NCT01676571
org study id: 14077A
nct id: NCT01676571
lead sponsor: 
has dmc: No
The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu
      AA21004 (Vortioxetine) in the Chinese population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PK AUC determination of Lu AA21004 (Vortioxetine)
time frame: 11 days
description: Area under the curve (AUC)
measure: PK Cmax determination of Lu AA21004 (Vortioxetine)
time frame: 11 days
description: Maximum observed concentration (Cmax)
measure: PK MR determination of metabolites Lu AA34443 and Lu AA39835
time frame: 11 days
description: Metabolic ratio (MR)
measure: Number of patients with adverse events as a measure of safety and tolerability
time frame: 11 days
arm group label: Lu AA21004
arm group type: Experimental
intervention type: Drug
intervention name: Lu AA21004
description: 10 mg immediate-release (IR), one single dose, orally
arm group label: Lu AA21004
other name: Vortioxetine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Email contact via H. Lundbeck A/S
role: Study Director
affiliation: LundbeckClinicalTrials@lundbeck.com
facility: 
country: China
responsible party type: Sponsor
mesh term: Vortioxetine