<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/NCT01678976</url>
  </required_header>
  <id_info>
    <org_study_id>BIA-2093-104</org_study_id>
    <nct_id>NCT01678976</nct_id>
  </id_info>
  <brief_title>Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers</brief_title>
  <official_title>Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bial - Portela C S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bial - Portela C S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single&#xD;
      900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a&#xD;
      single 900 mg dose of BIA 2-093 and Oxcarbazepine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single centre, open label, balanced randomised, two-way crossover study in 12 healthy&#xD;
      volunteers. The study consisted of 2 periods separated by a washout period of 7 days or more.&#xD;
      On each of the study periods the volunteers received either a single 900 mg oral dose of BIA&#xD;
      2-093 or a single 900 mg oral dose of Oxcarbazepine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2002</start_date>
  <completion_date type="Actual">April 2002</completion_date>
  <primary_completion_date type="Actual">April 2002</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>Maximum Drug Concentration (Cmax)</measure>
    <time_frame>at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose</time_frame>
    <description>Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Versus Time Curve (AUC)</measure>
    <time_frame>at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Total of Subjects Reporting at Least One Adverse Event</measure>
    <time_frame>4 weeks</time_frame>
    <description>Monitoring of Adverse Events throughout the study: Safety was evaluated from the number of reported adverse events (AEs) by patient</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Group 1 BIA 2-093 + Oxcarbazepine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 Oxcarbazepine + BIA 2-093</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIA 2-093</intervention_name>
    <description>Tablets containing BIA 2-093 in doses of 300 and 600 mg</description>
    <arm_group_label>Group 1 BIA 2-093 + Oxcarbazepine</arm_group_label>
    <arm_group_label>Group 2 Oxcarbazepine + BIA 2-093</arm_group_label>
    <other_name>Eslicarbazepine acetate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxcarbazepine</intervention_name>
    <description>Tablets containing 300 mg and 600 mg of Trileptal®</description>
    <arm_group_label>Group 1 BIA 2-093 + Oxcarbazepine</arm_group_label>
    <arm_group_label>Group 2 Oxcarbazepine + BIA 2-093</arm_group_label>
    <other_name>Trileptal®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects aged between 18 and 45 years, inclusive.&#xD;
&#xD;
          -  Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.&#xD;
&#xD;
          -  Subjects who were healthy as determined by pre-study medical history, physical&#xD;
             examination, neurological examination, and 12-lead ECG.&#xD;
&#xD;
          -  Subjects who had clinical laboratory tests acceptable.&#xD;
&#xD;
          -  Subjects who were negative for HBs Ag, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at&#xD;
             screening.&#xD;
&#xD;
          -  Subjects who were negative for alcohol and drugs of abuse at screening and admission.&#xD;
&#xD;
          -  Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per&#xD;
             day.&#xD;
&#xD;
          -  Subjects who were able and willing to give written informed consent.&#xD;
&#xD;
          -  In case of female volunteers, subjects who were not of childbearing potential by&#xD;
             reason of surgery or, if of childbearing potential, used one of the following methods&#xD;
             of contraception: double-barrier, intrauterine device or abstinence.&#xD;
&#xD;
          -  In case of female volunteers, subjects who had a negative pregnancy test at screening&#xD;
             and admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who did not conform to the above inclusion criteria.&#xD;
&#xD;
          -  Subjects who had a clinically relevant history or presence of respiratory,&#xD;
             gastrointestinal, renal, hepatic, haematological, lymphatic, neurological,&#xD;
             cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological,&#xD;
             dermatological, connective tissue diseases or disorders.&#xD;
&#xD;
          -  Subjects who had a clinically relevant surgical history.&#xD;
&#xD;
          -  Subjects who had a clinically relevant family history.&#xD;
&#xD;
          -  Subjects who had a history of relevant atopy.&#xD;
&#xD;
          -  Subjects who had a history of relevant drug hypersensitivity.&#xD;
&#xD;
          -  Subjects who had a history of alcoholism or drug abuse.&#xD;
&#xD;
          -  Subjects who consumed more than 21 units of alcohol a week.&#xD;
&#xD;
          -  Subjects who had a significant infection or known inflammatory process on screening&#xD;
             and/or admission.&#xD;
&#xD;
          -  Subjects who had acute gastrointestinal symptoms at the time of screening and/or&#xD;
             admission (e.g., nausea, vomiting, diarrhoea, heartburn).&#xD;
&#xD;
          -  Subjects who had used prescription drugs within 4 weeks of first dosing.&#xD;
&#xD;
          -  Subjects who had used over-the-counter medication excluding oral routine vitamins but&#xD;
             including mega dose vitamin therapy within one week of first dosing.&#xD;
&#xD;
          -  Subjects who had used any investigational drug and/or participated in any clinical&#xD;
             trial within 2 months of their first admission.&#xD;
&#xD;
          -  Subjects who had previously received BIA 2-093.&#xD;
&#xD;
          -  Subjects who had donated and/or received any blood or blood products within the&#xD;
             previous 2 months prior to screening.&#xD;
&#xD;
          -  Subjects who were vegetarians, vegans and/or had medical dietary restrictions.&#xD;
&#xD;
          -  Subjects who could not communicate reliably with the investigator.&#xD;
&#xD;
          -  Subjects who were unlikely to co-operate with the requirements of the study.&#xD;
&#xD;
          -  Subjects who were unwilling or unable to give written informed consent.&#xD;
&#xD;
          -  In case of female volunteers, subjects who were pregnant or breast-feeding.&#xD;
&#xD;
          -  In case of female volunteers, subjects who were of childbearing potential and did not&#xD;
             use an approved effective contraceptive method or used oral contraceptives.&#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>Manuel Vaz-da-Silva, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BIAL - Portela &amp; Cª S.A</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BIAL - Portela &amp; Cª - Human Pharmacology Unit (UFH)</name>
      <address>
        <city>S. Mamede do Coronado</city>
        <state>Trofa</state>
        <zip>4745-457</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <results_first_submitted>November 28, 2014</results_first_submitted>
  <results_first_submitted_qc>December 19, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 8, 2015</results_first_posted>
  <last_update_submitted>December 19, 2014</last_update_submitted>
  <last_update_submitted_qc>December 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Eslicarbazepine acetate</keyword>
  <keyword>Epilepsy</keyword>
  <keyword>Oxcarbazepine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eslicarbazepine acetate</mesh_term>
    <mesh_term>Oxcarbazepine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Period 1 - BIA 2-093; Period 2 - Oxcarbazepine</title>
          <description>Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine</description>
        </group>
        <group group_id="P2">
          <title>Period 1 - Oxcarbazepine; Period 2 - BIA 2-093</title>
          <description>Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Period 1 - BIA 2-093; Period 2 - Oxcarbazepine</title>
          <description>Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine</description>
        </group>
        <group group_id="B2">
          <title>Period 1 - Oxcarbazepine; Period 2 - BIA 2-093</title>
          <description>Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Drug Concentration (Cmax)</title>
        <description>Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.</description>
        <time_frame>at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose</time_frame>
        <population>Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.</population>
        <group_list>
          <group group_id="O1">
            <title>BIA 2-093 900 mg od</title>
            <description>BIA 2-093, ESL Eslicarbazepine acetate</description>
          </group>
          <group group_id="O2">
            <title>Oxcarbazepine 900 mg od</title>
            <description>Oxcarbazepine, Trileptal®</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Drug Concentration (Cmax)</title>
          <description>Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.</description>
          <population>Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cmax (BIA 2-194)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15753" spread="3781"/>
                    <measurement group_id="O2" value="5978" spread="1136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cmax (BIA 2-195)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="428" spread="88.6"/>
                    <measurement group_id="O2" value="1708" spread="751"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cmax (Oxcarbazepine)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140" spread="37.7"/>
                    <measurement group_id="O2" value="1268" spread="656"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration Versus Time Curve (AUC)</title>
        <description>Area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.</description>
        <time_frame>at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose</time_frame>
        <population>Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.</population>
        <group_list>
          <group group_id="O1">
            <title>BIA 2-093 900 mg od</title>
            <description>BIA 2-093, ESL, Eslicarbazepine acetate</description>
          </group>
          <group group_id="O2">
            <title>Oxcarbazepine 900 mg od</title>
            <description>Oxcarbazepine, Trileptal®</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Versus Time Curve (AUC)</title>
          <description>Area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.</description>
          <population>Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.</population>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AUC0-t (BIA 2-194)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299065" spread="65077"/>
                    <measurement group_id="O2" value="214433" spread="45162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUC0-t (BIA 2-195)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13877" spread="2867"/>
                    <measurement group_id="O2" value="49124" spread="18926"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUC0-t (Oxcarbazepine)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1821" spread="693"/>
                    <measurement group_id="O2" value="6549" spread="3927"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Total of Subjects Reporting at Least One Adverse Event</title>
        <description>Monitoring of Adverse Events throughout the study: Safety was evaluated from the number of reported adverse events (AEs) by patient</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BIA 2-093</title>
            <description>BIA 2-093, ESL, Eslicarbazepine</description>
          </group>
          <group group_id="O2">
            <title>Oxcarbazepine</title>
            <description>Oxcarbazepine, Trileptal</description>
          </group>
        </group_list>
        <measure>
          <title>Total of Subjects Reporting at Least One Adverse Event</title>
          <description>Monitoring of Adverse Events throughout the study: Safety was evaluated from the number of reported adverse events (AEs) by patient</description>
          <units>subjects reporting at least 1 AE</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All treatment-emergent AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Possibly related to treatment AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>BIA 2-093</title>
          <description>BIA 2-093, ESL, Eslicarbazepine</description>
        </group>
        <group group_id="E2">
          <title>Oxcarbazepine</title>
          <description>Oxcarbazepine, Trileptal</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MeDRA (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Sensation of pressure in ear</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain NOS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site bruise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Venipuncture site bruise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>CPK increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Concentration impairment</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lipothymia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nystagmus NOS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Parasthesiae circumoral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Taste bitter</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Thinking reduced</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Syncope vasovagal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dry cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sore throat NOS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Nodule subcutaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Head of Clinical Research</name_or_title>
      <organization>Bial - Portela &amp; Cª, S.A.</organization>
      <phone>+351 229 866 100</phone>
      <email>francisco.rocha@bial.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01678976
org study id: BIA-2093-104
nct id: NCT01678976
lead sponsor: 
has dmc: No
To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single
      900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a
      single 900 mg dose of BIA 2-093 and Oxcarbazepine.
Single centre, open label, balanced randomised, two-way crossover study in 12 healthy
      volunteers. The study consisted of 2 periods separated by a washout period of 7 days or more.
      On each of the study periods the volunteers received either a single 900 mg oral dose of BIA
      2-093 or a single 900 mg oral dose of Oxcarbazepine.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Drug Concentration (Cmax)
time frame: at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
description: Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.
measure: Area Under the Plasma Concentration Versus Time Curve (AUC)
time frame: at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
description: Area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.
measure: Total of Subjects Reporting at Least One Adverse Event
time frame: 4 weeks
description: Monitoring of Adverse Events throughout the study: Safety was evaluated from the number of reported adverse events (AEs) by patient
arm group label: Group 1 BIA 2-093 + Oxcarbazepine
arm group type: Experimental
description: Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
arm group label: Group 2 Oxcarbazepine + BIA 2-093
arm group type: Active Comparator
description: Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
intervention type: Drug
intervention name: BIA 2-093
description: Tablets containing BIA 2-093 in doses of 300 and 600 mg
arm group label: Group 1 BIA 2-093 + Oxcarbazepine
arm group label: Group 2 Oxcarbazepine + BIA 2-093
other name: Eslicarbazepine acetate
intervention type: Drug
intervention name: Oxcarbazepine
description: Tablets containing 300 mg and 600 mg of Trileptal®
arm group label: Group 1 BIA 2-093 + Oxcarbazepine
arm group label: Group 2 Oxcarbazepine + BIA 2-093
other name: Trileptal®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Manuel Vaz-da-Silva, MD, PhD
role: Principal Investigator
affiliation: BIAL - Portela & Cª S.A
facility: 
country: Portugal
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Eslicarbazepine acetate
mesh term: Oxcarbazepine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 