<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/NCT01702623</url>
  </required_header>
  <id_info>
    <org_study_id>OXCA-S600-PVFS-2</org_study_id>
    <nct_id>NCT01702623</nct_id>
  </id_info>
  <brief_title>Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions</brief_title>
  <official_title>A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roxane Laboratories</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West-Ward Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'&#xD;
      Oxcarbazepine Suspension 600 mg under fasted conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">September 2009</completion_date>
  <primary_completion_date type="Actual">September 2009</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>bioequivalence determined by statistical comparison Cmax</measure>
    <time_frame>10 Days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Seizures</condition>
  <arm_group>
    <arm_group_label>Oxcarbazepine first, then Trileptal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trileptal first, then Oxcarbazepine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxcarbazepine</intervention_name>
    <arm_group_label>Oxcarbazepine first, then Trileptal</arm_group_label>
    <arm_group_label>Trileptal first, then Oxcarbazepine</arm_group_label>
    <other_name>Trileptal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No clinically significant abnormal findings on the physical examination, medical&#xD;
             history, or clinical laboratory results during screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive test for HIV, Hepatitis B, or Hepatitis C.&#xD;
&#xD;
          -  Treatment with known enzyme altering drugs.&#xD;
&#xD;
          -  History of allergic or adverse response to oxcarbazepine or any comparable or similar&#xD;
             product.&#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>Cynthia Zamora, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>January 19, 2018</last_update_submitted>
  <last_update_submitted_qc>January 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxcarbazepine</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/NCT01702623
org study id: OXCA-S600-PVFS-2
nct id: NCT01702623
lead sponsor: 
has dmc: No
The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Oxcarbazepine Suspension 600 mg under fasted conditions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: bioequivalence determined by statistical comparison Cmax
time frame: 10 Days
arm group label: Oxcarbazepine first, then Trileptal
arm group type: Active Comparator
description: Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period)
arm group label: Trileptal first, then Oxcarbazepine
arm group type: Active Comparator
description: Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period
intervention type: Drug
intervention name: Oxcarbazepine
arm group label: Oxcarbazepine first, then Trileptal
arm group label: Trileptal first, then Oxcarbazepine
other name: Trileptal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cynthia Zamora, MD
role: Principal Investigator
affiliation: Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Seizures
mesh term: Oxcarbazepine