<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/NCT02191241</url>
  </required_header>
  <id_info>
    <org_study_id>1138.9</org_study_id>
    <nct_id>NCT02191241</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of a Single Oral Dose of 1,800 mg Red Vine Leaf Extract (Antistax®)</brief_title>
  <official_title>An Open, Uncontrolled Trial in Healthy Volunteers to Explore the Plasma and Urinary Pharmacokinetics of a Single Oral Dose of 1,800 mg Red Vine Leaf Extract (Antistax®)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To describe the plasma and urinary pharmacokinetics of quercetin glucuronide and kaempferol&#xD;
      glucuronide after the administration of a single peroral dose of 1,800mg Red Vine Leaf&#xD;
      Extract (Antistax®). Additionally, the trial evaluated the safety and tolerability of this&#xD;
      dose in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2001</start_date>
  <primary_completion_date type="Actual">September 2004</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>maximum concentration of the analyte (Cmax)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>area under the curve (AUC) extrapolated to infinity (AUC0-inf)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>time to Cmax (Tmax)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC under the time course of the quantifiable concentrations (AUC0-tz)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apparent terminal disposition rate constant (λz)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apparent terminal half-life (t1/2)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Red Vine Leaf Extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Red Vine Leaf Extract</intervention_name>
    <arm_group_label>Red Vine Leaf Extract</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female (if female: either of non-childbearing potential or taking adequate&#xD;
             contraceptive measures)&#xD;
&#xD;
          -  caucasian&#xD;
&#xD;
          -  age: 18 to 40 years old&#xD;
&#xD;
          -  body mass index (BMI): 18-28 kg x m-2&#xD;
&#xD;
          -  subjects who - on the basis of extensive pre-trial investigation - could be considered&#xD;
             to be healthy&#xD;
&#xD;
          -  subjects who were willing and capable to confirm written consent to enrolment after&#xD;
             ample information has been provided&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  if female: positive pregnancy test upon recruitment&#xD;
&#xD;
          -  subjects with any relevant clinical abnormality (as based on extensive medical&#xD;
             history, physical examination, vital signs)&#xD;
&#xD;
          -  subjects with chronic or relevant acute infections&#xD;
&#xD;
          -  subjects with therapy-requiring allergies (including drug allergies)&#xD;
&#xD;
          -  subjects with suspicion of hypersensitivity to the investigational medication&#xD;
&#xD;
          -  subjects with any clinically relevant laboratory abnormality (including positive&#xD;
             results for hepatitis and HIV serology)&#xD;
&#xD;
          -  subjects who had received any medication within 1 week prior to trial start or during&#xD;
             the trial, except for hormonal contraceptives (females) or thyroid hormone replacement&#xD;
             after thyroidectomy&#xD;
&#xD;
          -  subjects who had taken a drug with a long half-life (≥ 24 hours) within one month&#xD;
             before enrolment in the trial&#xD;
&#xD;
          -  subjects who participated in a trial with a novel investigational medication within&#xD;
             the last 8 weeks before the start of the present trial&#xD;
&#xD;
          -  subjects who participated in a trial with a registered compound within the last 4&#xD;
             weeks before the start of the present trial&#xD;
&#xD;
          -  subjects who donated blood or plasma within the last 4 weeks before the start of the&#xD;
             present trial&#xD;
&#xD;
          -  subjects who smoked more than 15 cigarettes per day and subjects who were not willing&#xD;
             or able to abstain from smoking from 12:00 hours before and during the profiling days&#xD;
&#xD;
          -  subjects known or suspected to be (social) drug dependent, incl. those drinking more&#xD;
             than 60 g alcohol per day and who were not willing to abstain from alcohol during the&#xD;
             active trial phase&#xD;
&#xD;
          -  subjects adhering to a diet (i.e. vegetarian) or lifestyle (including extreme physical&#xD;
             activities such as competitive sports and weight lifting) that might interfere with&#xD;
             the investigation&#xD;
&#xD;
          -  subjects known or suspected not to comply with the trial directives and/or known or&#xD;
             suspected not to be reliable or trustworthy&#xD;
&#xD;
          -  subjects known or suspected not to be capable of understanding and evaluating the&#xD;
             information that is given to them as part of the formal information policy (informed&#xD;
             consent), in particular regarding the risks and discomfort to which they would agree&#xD;
             to be exposed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 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/1138/1138.9_U06-0085.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>August 29, 2018</last_update_submitted>
  <last_update_submitted_qc>August 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</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/NCT02191241
org study id: 1138.9
nct id: NCT02191241
lead sponsor: 
To describe the plasma and urinary pharmacokinetics of quercetin glucuronide and kaempferol
      glucuronide after the administration of a single peroral dose of 1,800mg Red Vine Leaf
      Extract (Antistax®). Additionally, the trial evaluated the safety and tolerability of this
      dose in healthy subjects.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: maximum concentration of the analyte (Cmax)
time frame: up to 24 hours after drug administration
measure: area under the curve (AUC) extrapolated to infinity (AUC0-inf)
time frame: up to 24 hours after drug administration
measure: time to Cmax (Tmax)
time frame: up to 24 hours after drug administration
measure: AUC under the time course of the quantifiable concentrations (AUC0-tz)
time frame: up to 24 hours after drug administration
measure: apparent terminal disposition rate constant (λz)
time frame: up to 24 hours after drug administration
measure: apparent terminal half-life (t1/2)
time frame: up to 24 hours after drug administration
measure: Mean residence time (MRT)
time frame: up to 24 hours after drug administration
arm group label: Red Vine Leaf Extract
arm group type: Experimental
intervention type: Drug
intervention name: Red Vine Leaf Extract
arm group label: Red Vine Leaf Extract
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1138/1138.9_U06-0085.pdf
description: Related Info
responsible party type: Sponsor