<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/NCT02191787</url>
  </required_header>
  <id_info>
    <org_study_id>1135.2</org_study_id>
    <nct_id>NCT02191787</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers</brief_title>
  <official_title>Pharmacokinetic-pharmacodynamic Assessment of Seresis® o.d.: an Open, Uncontrolled, Non-randomised Intraindividual Pilot-study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers and&#xD;
      the optimal time for blood sampling&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 1998</start_date>
  <primary_completion_date type="Actual">May 1998</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in total antioxidant activity of Seresis®</measure>
    <time_frame>Baseline, Day 2</time_frame>
    <description>determined by chemoluminescence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in total antioxidant activity of Seresis®</measure>
    <time_frame>Day 2, day 6</time_frame>
    <description>determined by chemoluminescence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability on a 4-point scale</measure>
    <time_frame>Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to day 14</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Seresis® + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 capsules Seresis® o.d. for 5 days&#xD;
2 capsules Placebo o.d. the day before treatment with Seresis®</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Seresis®</intervention_name>
    <arm_group_label>Seresis® + Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Seresis® + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The subjects to be enrolled are healthy volunteers, defined as follows:&#xD;
&#xD;
          -  Healthy men or women between 18 and 30 years old&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Fit for work&#xD;
&#xD;
          -  Having given informed consent and signed the form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any serious disorder that might interfere with his/her participation in this study and&#xD;
             the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic&#xD;
             dysfunction, cardiovascular disease, hypervitaminosis A, psychic disorder etc.).&#xD;
&#xD;
          -  Treatment with other drug that might interfere with the evaluation of the safety of&#xD;
             the test drug&#xD;
&#xD;
          -  Known hypersensitivity to any of the ingredients of the study drug&#xD;
&#xD;
          -  Pregnancy, lactation, women of childbearing potential who do not use an established&#xD;
             contraceptive&#xD;
&#xD;
          -  Drug and alcohol abuse&#xD;
&#xD;
          -  Participation in another trial&#xD;
&#xD;
          -  Known abnormal values of the laboratory tests (if detected after enrolment, subjects&#xD;
             will continue the treatment provided there are not medical objections)&#xD;
&#xD;
          -  Specific dietary requirements that do not allow the volunteers to meet the dietary&#xD;
             guidelines set out for this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1135/1135.2_U98-0261.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02191787
org study id: 1135.2
nct id: NCT02191787
lead sponsor: 
Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers and
      the optimal time for blood sampling
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in total antioxidant activity of Seresis®
time frame: Baseline, Day 2
description: determined by chemoluminescence
measure: Changes in total antioxidant activity of Seresis®
time frame: Day 2, day 6
description: determined by chemoluminescence
measure: Assessment of tolerability on a 4-point scale
time frame: Day 14
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to day 14
measure: Number of patients with adverse events
time frame: up to day 14
arm group label: Seresis® + Placebo
arm group type: Experimental
description: 2 capsules Seresis® o.d. for 5 days
2 capsules Placebo o.d. the day before treatment with Seresis®
intervention type: Drug
intervention name: Seresis®
arm group label: Seresis® + Placebo
intervention type: Drug
intervention name: Placebo
arm group label: Seresis® + Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1135/1135.2_U98-0261.pdf
description: Related Info
responsible party type: Sponsor