<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/NCT01699724</url>
  </required_header>
  <id_info>
    <org_study_id>A0501098</org_study_id>
    <nct_id>NCT01699724</nct_id>
  </id_info>
  <brief_title>Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects</brief_title>
  <official_title>Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Assessing Bioequivalence Of Zoloft ODT 50 Mg Under Fasting Condition With And Without Water To Jzoloft Tablet 50 Mg Under Fasting Condition With Water In Healthy Japanese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer's Upjohn has merged with Mylan to form Viatris Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and&#xD;
      without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition&#xD;
      with water in Healthy Japanese Subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC from zero to the last sampling point (AUCt) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions</measure>
    <time_frame>0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions</measure>
    <time_frame>0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax and AUCt of sertraline after dose of sertraline ODT 50 mg with water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions</measure>
    <time_frame>0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of maximum plasma concentration of sertraline ODT 50 mg with water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions</measure>
    <time_frame>0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC from zero to infinity or last measurable concentration of sertraline after dose of sertraline ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions</measure>
    <time_frame>0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination rate constant (kel), half-life (t½) and mean residence time (MRT) of sertraline ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions</measure>
    <time_frame>0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety laboratory tests, vital signs, and adverse events (AEs)</measure>
    <time_frame>From Periods 1 to 3</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>JZoloft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral tablet of sertraline hydrochloride (Japanese commercial tablet: JZoloft ® tablet) 50 mg as a single oral dose under fasted conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ODT without water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sertraline ODT 50 mg without water as a single oral dose under fasted conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ODT with water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sertraline ODT 50 mg with water as a single oral dose under fasted conditions</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JZoloft</intervention_name>
    <description>50 mg tablet on Day 1 of each period</description>
    <arm_group_label>JZoloft</arm_group_label>
    <other_name>sertraline hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sertraline ODT</intervention_name>
    <description>50 mg tablet on Day 1 of each period</description>
    <arm_group_label>ODT without water</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sertraline ODT</intervention_name>
    <description>50 mg tablet on Day 1 of each period</description>
    <arm_group_label>ODT with water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Japanese subjects between the ages of 20 and 55 years.&#xD;
&#xD;
          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight &gt;50 kg (110 lbs).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant psychiatric disorder, recurrent episodes of severe depression, or subjects&#xD;
             with serious suicidal risk per criteria.&#xD;
&#xD;
          -  Pregnant or nursing females; females of childbearing potential who are unwilling or&#xD;
             unable to use an acceptable method of nonhormonal contraception as outlined in this&#xD;
             protocol from at least 14 days prior to the first dose of study medication and for 28&#xD;
             days after the last dose of study medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Hachioji-shi</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0501098&amp;StudyName=Bioequivalence%20Of%20Zoloft%20ODT%20To%20Jzoloft%20In%20Healthy%20Japanese%20Subjects</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>JZoloft</keyword>
  <keyword>Sertraline hydrochloride</keyword>
  <keyword>ODT</keyword>
  <keyword>bioequivalence</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sertraline</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/NCT01699724
org study id: A0501098
nct id: NCT01699724
lead sponsor: 
has dmc: No
The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and
      without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition
      with water in Healthy Japanese Subjects
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: AUC from zero to the last sampling point (AUCt) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
time frame: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
measure: Maximum plasma concentration (Cmax) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
time frame: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
measure: Cmax and AUCt of sertraline after dose of sertraline ODT 50 mg with water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
time frame: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
measure: Time of maximum plasma concentration of sertraline ODT 50 mg with water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
time frame: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
measure: AUC from zero to infinity or last measurable concentration of sertraline after dose of sertraline ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
time frame: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
measure: Terminal elimination rate constant (kel), half-life (t½) and mean residence time (MRT) of sertraline ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
time frame: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
measure: Safety laboratory tests, vital signs, and adverse events (AEs)
time frame: From Periods 1 to 3
arm group label: JZoloft
arm group type: Active Comparator
description: Oral tablet of sertraline hydrochloride (Japanese commercial tablet: JZoloft ® tablet) 50 mg as a single oral dose under fasted conditions
arm group label: ODT without water
arm group type: Experimental
description: sertraline ODT 50 mg without water as a single oral dose under fasted conditions
arm group label: ODT with water
arm group type: Experimental
description: sertraline ODT 50 mg with water as a single oral dose under fasted conditions
intervention type: Drug
intervention name: JZoloft
description: 50 mg tablet on Day 1 of each period
arm group label: JZoloft
other name: sertraline hydrochloride
intervention type: Drug
intervention name: sertraline ODT
description: 50 mg tablet on Day 1 of each period
arm group label: ODT without water
intervention type: Drug
intervention name: sertraline ODT
description: 50 mg tablet on Day 1 of each period
arm group label: ODT with water
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: Japan
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0501098&StudyName=Bioequivalence%20Of%20Zoloft%20ODT%20To%20Jzoloft%20In%20Healthy%20Japanese%20Subjects
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Sertraline