<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/NCT03819491</url>
  </required_header>
  <id_info>
    <org_study_id>VF-BAQ10/2018</org_study_id>
    <nct_id>NCT03819491</nct_id>
  </id_info>
  <brief_title>Bioavailability Study of COQUN ORAL FORMULATION</brief_title>
  <official_title>Bioavailability Study of COQUN ORAL FORMULATION (CoQ10) Administered in Healthy Adults (CoQ10-01)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VISUfarma SpA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VISUfarma SpA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the study is to evaluate the best dosage for COQUN ORAL FORMULATION in order to&#xD;
      reach a level of plasma concentration which might assure its antioxidant effect if taken on a&#xD;
      regular basis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include 24 healthy subjects who will test the CoQ10 formulation. All 24&#xD;
      subjects will test a single dose of 100mg CoQ10 in 1 day to assess bioavailability, which&#xD;
      will be followed by a one week wash-out period and then by a 4 week period of continuous&#xD;
      administration of COQUN ORAL FORMULATION in parallel groups (1:1): patients will be divided&#xD;
      in the continuous treatment period into two groups, one group of 12 patients with intake of&#xD;
      100mg OD, the other one group of 12 patients with intake of 100mg BID, in order to assess&#xD;
      multiple-dose profile of COQUN ORAL FORMULATION.&#xD;
&#xD;
      Patients will have to fast the night before enrolment, for at least 10 hours. Patients will&#xD;
      be requested to fill in a short diary in the multidose phase, on a daily basis, for&#xD;
      confirming the product correct intake, and informing on any experienced adverse event and&#xD;
      eventual medication taken for its solving.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2018</start_date>
  <completion_date type="Actual">August 29, 2018</completion_date>
  <primary_completion_date type="Actual">August 29, 2018</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>Parallel Assignment</intervention_model>
    <intervention_model_description>To evaluate the best dosage between 100 mg OD or 100 mg BID for COQUN ORAL FORMULATION in order to reach a level of plasma concentration which might assure its antioxidant effect if taken on a regular basis.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis of Pharmacokinetic Property &quot;Area Under the Curve&quot;</measure>
    <time_frame>from day-7 to day 28</time_frame>
    <description>- Area under the curve (microg/ml x h): ≥5&#xD;
Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.&#xD;
Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of Pharmacokinetic Property &quot;Cmax&quot;</measure>
    <time_frame>from day-7 to day 28</time_frame>
    <description>- Cmax: ≥0,8&#xD;
Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.&#xD;
Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of Pharmacokinetic Property &quot;Tmax&quot;</measure>
    <time_frame>from day-7 to day 28</time_frame>
    <description>- Tmax: ≥3&#xD;
Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.&#xD;
Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Male &amp; Female Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 mg OD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 mg BID</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>COQUN ORAL FORMULATION</intervention_name>
    <description>COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject Informed consent form (ICF) is signed&#xD;
&#xD;
          -  M &amp; F Aged between 35-75 years at the time of the signature of ICF&#xD;
&#xD;
          -  A body mass index between 20 and 29 kg/m2&#xD;
&#xD;
          -  Fasting the night before enrolment, for at least 10 hours&#xD;
&#xD;
          -  Healthy, meaning absence of any prescribed medication for a month prior to the&#xD;
             inclusion to the study and during the study&#xD;
&#xD;
          -  Willing to avoid a consumption of any food supplements except vitamin D and calcium at&#xD;
             least 2 weeks before and during the study&#xD;
&#xD;
          -  Consumption of dairy and cereal products (standardized breakfast will include low&#xD;
             lactose dairy and bread)&#xD;
&#xD;
          -  Willing to follow all study procedures, including attending all site visits (including&#xD;
             sessions during which a venous line will be inserted for blood sampling), and keeping&#xD;
             a diary for the time of multiple-dose study (to follow their compliance and&#xD;
             palatability)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intake of any prescribed medication within 2 weeks of the beginning of the study&#xD;
&#xD;
          -  Intake of any food supplements within 2 weeks of the beginning of the study, except&#xD;
             vitamin D and calcium&#xD;
&#xD;
          -  Hypotension&#xD;
&#xD;
          -  Any clinically significant history of serious digestive tract, liver, kidney,&#xD;
             cardiovascular or hematological disease, diabetes&#xD;
&#xD;
          -  Gastrointestinal disorders or other serious acute or chronic diseases&#xD;
&#xD;
          -  Known lactose/gluten intolerances/ food allergies (limitation for standardization of&#xD;
             meals)&#xD;
&#xD;
          -  Inadequate veins (in the opinion of the investigator) or known contraindication to&#xD;
             placement of a dedicated peripheral line for venous blood withdrawal&#xD;
&#xD;
          -  Known drug and/or alcohol abuse&#xD;
&#xD;
          -  Using any form of nicotine or tobacco&#xD;
&#xD;
          -  Mental incapacity that precludes adequate understanding or cooperation&#xD;
&#xD;
          -  Participation in another investigational study or blood donation within 3 months prior&#xD;
             to or during this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Consult Med Iasi</name>
      <address>
        <city>Iasi</city>
        <state>Iasi County, Romania</state>
        <zip>550</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <results_first_submitted>May 9, 2019</results_first_submitted>
  <results_first_submitted_qc>July 26, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 6, 2019</results_first_posted>
  <last_update_submitted>July 26, 2019</last_update_submitted>
  <last_update_submitted_qc>July 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COQUN</keyword>
  <keyword>antioxidant</keyword>
  <keyword>Bioavailability</keyword>
  <keyword>CoQ10</keyword>
  <keyword>Healthy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03819491/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03819491/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CoQ10 Once Daily</title>
          <description>100 mg OD&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
        </group>
        <group group_id="P2">
          <title>CoQ10 Twice a Day</title>
          <description>100 mg BID&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Before Randomization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="0"/>
              </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>
          <title>After Randomization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </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>CoQ10 Once Daily</title>
          <description>100 mg OD&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
        </group>
        <group group_id="B2">
          <title>CoQ10 Twice a Day</title>
          <description>100 mg BID&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</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="12"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35" spread="7"/>
                    <measurement group_id="B2" value="43" spread="7"/>
                    <measurement group_id="B3" value="39" spread="7"/>
                  </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="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>Asian</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>Native Hawaiian or Other Pacific Islander</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>Black or African American</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>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Analysis of Pharmacokinetic Property &quot;Area Under the Curve&quot;</title>
        <description>- Area under the curve (microg/ml x h): ≥5&#xD;
Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.&#xD;
Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.</description>
        <time_frame>from day-7 to day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CoQ10 Once Daily</title>
            <description>100 mg OD&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
          </group>
          <group group_id="O2">
            <title>CoQ10 Twice a Day</title>
            <description>100 mg BID&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Pharmacokinetic Property &quot;Area Under the Curve&quot;</title>
          <description>- Area under the curve (microg/ml x h): ≥5&#xD;
Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.&#xD;
Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.</description>
          <units>microg/l*days</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2657.45" lower_limit="2224.3" upper_limit="3090.6"/>
                    <measurement group_id="O2" value="3459.05" lower_limit="2806.7" upper_limit="4111.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Analysis of Pharmacokinetic Property &quot;Cmax&quot;</title>
        <description>- Cmax: ≥0,8&#xD;
Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.&#xD;
Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.</description>
        <time_frame>from day-7 to day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CoQ10 Once Daily</title>
            <description>100 mg OD&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
          </group>
          <group group_id="O2">
            <title>CoQ10 Twice a Day</title>
            <description>100 mg BID&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Pharmacokinetic Property &quot;Cmax&quot;</title>
          <description>- Cmax: ≥0,8&#xD;
Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.&#xD;
Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.</description>
          <units>microg/l</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1163.99" lower_limit="938.46" upper_limit="1389.51"/>
                    <measurement group_id="O2" value="1501.89" lower_limit="1200.32" upper_limit="1803.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Analysis of Pharmacokinetic Property &quot;Tmax&quot;</title>
        <description>- Tmax: ≥3&#xD;
Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.&#xD;
Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.</description>
        <time_frame>from day-7 to day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CoQ10 Once Daily</title>
            <description>100 mg OD&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
          </group>
          <group group_id="O2">
            <title>CoQ10 Twice a Day</title>
            <description>100 mg BID&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Pharmacokinetic Property &quot;Tmax&quot;</title>
          <description>- Tmax: ≥3&#xD;
Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.&#xD;
Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" lower_limit="11.07" upper_limit="23.93"/>
                    <measurement group_id="O2" value="16.92" lower_limit="11.4" upper_limit="22.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AE were collected for the total duration of the study (28 days).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CoQ10 Once Daily After Randomization</title>
          <description>100 mg OD&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
        </group>
        <group group_id="E2">
          <title>CoQ10 Twice a Day After Randomization</title>
          <description>100 mg BID&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
        </group>
        <group group_id="E3">
          <title>CoQ10 Once Daily Before Randomization</title>
          <description>100 mg OD&#xD;
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <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="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>PULTACEOUS ANGINA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>RESPIRATORY VIROSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Delia Reurean-Pintilei</name_or_title>
      <organization>Consult Med Iasi</organization>
      <phone>+40232233387</phone>
      <email>drdeliapintilei@gmail.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/NCT03819491
org study id: VF-BAQ10/2018
nct id: NCT03819491
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of the study is to evaluate the best dosage for COQUN ORAL FORMULATION in order to
      reach a level of plasma concentration which might assure its antioxidant effect if taken on a
      regular basis.
The study will include 24 healthy subjects who will test the CoQ10 formulation. All 24
      subjects will test a single dose of 100mg CoQ10 in 1 day to assess bioavailability, which
      will be followed by a one week wash-out period and then by a 4 week period of continuous
      administration of COQUN ORAL FORMULATION in parallel groups (1:1): patients will be divided
      in the continuous treatment period into two groups, one group of 12 patients with intake of
      100mg OD, the other one group of 12 patients with intake of 100mg BID, in order to assess
      multiple-dose profile of COQUN ORAL FORMULATION.

      Patients will have to fast the night before enrolment, for at least 10 hours. Patients will
      be requested to fill in a short diary in the multidose phase, on a daily basis, for
      confirming the product correct intake, and informing on any experienced adverse event and
      eventual medication taken for its solving.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: To evaluate the best dosage between 100 mg OD or 100 mg BID for COQUN ORAL FORMULATION in order to reach a level of plasma concentration which might assure its antioxidant effect if taken on a regular basis.
primary purpose: Other
masking: None (Open Label)
measure: Analysis of Pharmacokinetic Property "Area Under the Curve"
time frame: from day-7 to day 28
description: - Area under the curve (microg/ml x h): ≥5
Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.
Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.
measure: Analysis of Pharmacokinetic Property "Cmax"
time frame: from day-7 to day 28
description: - Cmax: ≥0,8
Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.
Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.
measure: Analysis of Pharmacokinetic Property "Tmax"
time frame: from day-7 to day 28
description: - Tmax: ≥3
Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.
Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.
arm group label: Group A
arm group type: Experimental
description: 100 mg OD
arm group label: Group B
arm group type: Experimental
description: 100 mg BID
intervention type: Dietary Supplement
intervention name: COQUN ORAL FORMULATION
description: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
arm group label: Group A
arm group label: Group B
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Romania
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 