<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/NCT03284814</url>
  </required_header>
  <id_info>
    <org_study_id>KME 89/07/17</org_study_id>
    <nct_id>NCT03284814</nct_id>
  </id_info>
  <brief_title>Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults</brief_title>
  <acronym>CoQ10-01</acronym>
  <official_title>Single-dose and Multiple-dose Comparative Bioavailability Study of Three CoQ10 Formulations in Healthy Elderly Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nutrition Institute, Slovenia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vizera d.o.o.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Valens Int. d.o.o., Slovenija</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>MEDEDUS, Ljubljana, Slovenia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nutrition Institute, Slovenia</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 single-center, randomized, open-label, three-period crossover bioavailability study will&#xD;
      include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations&#xD;
      of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed&#xD;
      with 2 weeks of continuous administration of one of study formulations to demonstrate and&#xD;
      assesse multiple-dose profile of CoQ10.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 29, 2017</start_date>
  <completion_date type="Actual">October 20, 2017</completion_date>
  <primary_completion_date type="Actual">October 20, 2017</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>improved single dose bioavailability of IP (in comparison to SP)</measure>
    <time_frame>48 hours</time_frame>
    <description>Relative bioavailability between the investigational and standard product expressed as ratio of AUC0-48h (area under the plasma concentration curve from the administration time to the last observation point, i.e. 48h) of total CoQ10 plasma concentrations above the baseline value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>improved plasma CoQ10 level after multiple dose study for IP (in comparison to SP)</measure>
    <time_frame>14 days</time_frame>
    <description>Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational and standard product.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>comparable single dose bioavailability of IP (in comparison to CP)</measure>
    <time_frame>48 hours</time_frame>
    <description>Relative bioavailability between the investigational product and comparator expressed as ratio of AUC0-48h of total CoQ10 plasma concentrations above the baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparable plasma CoQ10 level after multiple dose study for IP (in comparison to CP)</measure>
    <time_frame>14 days</time_frame>
    <description>Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational product and comparator.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Bioavailability of Coenzyme Q10</condition>
  <arm_group>
    <arm_group_label>Standard product group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will be included in a single dose cross over study, and in multiple dose study with standard product (SP: CoQ10 hard capsules; 100 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparative product group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will be included in a single dose cross over study, and in multiple dose study with comparative product (CP: CoQ10 soft-gel capsules; 100 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Investigational product group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be included in a single dose cross over study, and in multiple dose study with investigational product (IP: CoQ10 syrup; 100 mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Single dose intervention with Standard product (SP)</intervention_name>
    <description>hard capsules, 100 mg</description>
    <arm_group_label>Comparative product group</arm_group_label>
    <arm_group_label>Investigational product group</arm_group_label>
    <arm_group_label>Standard product group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Single dose intervention with Comparative product (CP)</intervention_name>
    <description>soft-gel capsules, 100 mg</description>
    <arm_group_label>Comparative product group</arm_group_label>
    <arm_group_label>Investigational product group</arm_group_label>
    <arm_group_label>Standard product group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Single dose intervention with Investigational product (IP)</intervention_name>
    <description>syrup, 100 mg</description>
    <arm_group_label>Comparative product group</arm_group_label>
    <arm_group_label>Standard product group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Multiple dose intervention with Standard product (SP)</intervention_name>
    <description>hard capsules, 100 mg - 14 days</description>
    <arm_group_label>Standard product group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Multiple dose intervention with Comparative product (CP)</intervention_name>
    <description>soft-gel capsules, 100 mg - 14 days</description>
    <arm_group_label>Comparative product group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Multiple dose intervention with Investigational product (IP)</intervention_name>
    <description>syrup, 100 mg - 14 days</description>
    <arm_group_label>Investigational product group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject Informed consent form (ICF) is singed&#xD;
&#xD;
          -  Aged between 65 and 74 years at the time of the signature of ICF&#xD;
&#xD;
          -  A body mass index between 20 and 29 kg/m2&#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 (standardised 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 standardisation 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>65 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Igor Pravst</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nutrition Institute, Ljubljana</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Snežana Kocijančič</last_name>
    <role>Principal Investigator</role>
    <affiliation>MEDEDUS, Ljubljana, Slovenia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MEDEDUS, Ljubljana, Slovenia</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nutrition Institute, Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vizera d.o.o., Ljubljana, Slovenia</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>March 18, 2019</last_update_submitted>
  <last_update_submitted_qc>March 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nutrition Institute, Slovenia</investigator_affiliation>
    <investigator_full_name>Snežana Kocijančič</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>coenzyme q10</keyword>
  <keyword>single dose bioavailability</keyword>
  <keyword>multiple dose bioavailability</keyword>
  <!-- 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/NCT03284814
org study id: KME 89/07/17
nct id: NCT03284814
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The single-center, randomized, open-label, three-period crossover bioavailability study will
      include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations
      of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed
      with 2 weeks of continuous administration of one of study formulations to demonstrate and
      assesse multiple-dose profile of CoQ10.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.
primary purpose: Other
masking: None (Open Label)
measure: improved single dose bioavailability of IP (in comparison to SP)
time frame: 48 hours
description: Relative bioavailability between the investigational and standard product expressed as ratio of AUC0-48h (area under the plasma concentration curve from the administration time to the last observation point, i.e. 48h) of total CoQ10 plasma concentrations above the baseline value.
measure: improved plasma CoQ10 level after multiple dose study for IP (in comparison to SP)
time frame: 14 days
description: Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational and standard product.
measure: comparable single dose bioavailability of IP (in comparison to CP)
time frame: 48 hours
description: Relative bioavailability between the investigational product and comparator expressed as ratio of AUC0-48h of total CoQ10 plasma concentrations above the baseline value.
measure: comparable plasma CoQ10 level after multiple dose study for IP (in comparison to CP)
time frame: 14 days
description: Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational product and comparator.
arm group label: Standard product group
arm group type: Active Comparator
description: This group will be included in a single dose cross over study, and in multiple dose study with standard product (SP: CoQ10 hard capsules; 100 mg)
arm group label: Comparative product group
arm group type: Active Comparator
description: This group will be included in a single dose cross over study, and in multiple dose study with comparative product (CP: CoQ10 soft-gel capsules; 100 mg)
arm group label: Investigational product group
arm group type: Experimental
description: This group will be included in a single dose cross over study, and in multiple dose study with investigational product (IP: CoQ10 syrup; 100 mg)
intervention type: Dietary Supplement
intervention name: Single dose intervention with Standard product (SP)
description: hard capsules, 100 mg
arm group label: Comparative product group
arm group label: Investigational product group
arm group label: Standard product group
intervention type: Dietary Supplement
intervention name: Single dose intervention with Comparative product (CP)
description: soft-gel capsules, 100 mg
arm group label: Comparative product group
arm group label: Investigational product group
arm group label: Standard product group
intervention type: Dietary Supplement
intervention name: Single dose intervention with Investigational product (IP)
description: syrup, 100 mg
arm group label: Comparative product group
arm group label: Standard product group
intervention type: Dietary Supplement
intervention name: Multiple dose intervention with Standard product (SP)
description: hard capsules, 100 mg - 14 days
arm group label: Standard product group
intervention type: Dietary Supplement
intervention name: Multiple dose intervention with Comparative product (CP)
description: soft-gel capsules, 100 mg - 14 days
arm group label: Comparative product group
intervention type: Dietary Supplement
intervention name: Multiple dose intervention with Investigational product (IP)
description: syrup, 100 mg - 14 days
arm group label: Investigational product group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Igor Pravst
role: Principal Investigator
affiliation: Nutrition Institute, Ljubljana
last name: Snežana Kocijančič
role: Principal Investigator
affiliation: MEDEDUS, Ljubljana, Slovenia
facility: 
facility: 
facility: 
country: Slovenia
responsible party type: Principal Investigator
investigator affiliation: Nutrition Institute, Slovenia
investigator full name: Snežana Kocijančič
investigator title: PhD