<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/NCT02259998</url>
  </required_header>
  <id_info>
    <org_study_id>21.449</org_study_id>
    <nct_id>NCT02259998</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets in Healthy Male Volunteers</brief_title>
  <official_title>An Open-labelled, Randomised, 2-way Crossover Study to Compare the Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets 75 mg p.o. (Present and Proposed Formulation in France) q.i.d. for Three Days in Healthy Male Volunteers</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 investigate the relative bioavailability of the proposed formulation of PERSANTIN®&#xD;
      compared to the present commercial formulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2001</start_date>
  <primary_completion_date type="Actual">December 2001</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>Area under the concentration time curve from 48 to 58 hours (AUC48-58)</measure>
    <time_frame>48 - 58 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum concentration from 48 to 58 hours (Cmax48-58)</measure>
    <time_frame>48 - 58 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak trough fluctuation (% PTF)</measure>
    <time_frame>up to 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum concentration from 48 to 58 hours (Cmin48-58)</measure>
    <time_frame>48 - 58 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax48-58/AUC48-58 ratio</measure>
    <time_frame>48 - 58 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration from 48 to 58 hours (Tmax48-58)</measure>
    <time_frame>up to 58 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount excreted in urine (Ae)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in vital functions</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
    <description>blood pressure, pulse rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in ECG</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Persantin® new formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Persantin® commercial formulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Persantin® new formulation</intervention_name>
    <arm_group_label>Persantin® new formulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Persantin® commercial formulation</intervention_name>
    <arm_group_label>Persantin® commercial formulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants in the study should be healthy males, range from 21 to 50 years of&#xD;
             age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2&#xD;
&#xD;
          -  All participants must give their written informed consent in accordance with Good&#xD;
             Clinical Practice and local legislation prior to admission to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within at least one month or less&#xD;
             than 10 half-lives of the respective drug before enrolment in the study or during the&#xD;
             study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial up to 7 days prior to&#xD;
             enrolment in the study or during the study&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (&lt;= two months prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (&gt;= 100 ml within four weeks prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the clinically accepted reference range&#xD;
&#xD;
          -  Excessive physical activities within the last week before the trial or during the&#xD;
             trial&#xD;
&#xD;
        Following exclusion criteria are of special interest for this study:&#xD;
&#xD;
          -  History of haemorrhagic diathesis&#xD;
&#xD;
          -  History of gastro-intestinal ulcer, perforation or bleeding&#xD;
&#xD;
          -  Glucose-6-phosphate-dehydrogenase (G-6-PD) deficiency&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dipyridamole</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02259998
org study id: 21.449
nct id: NCT02259998
lead sponsor: 
To investigate the relative bioavailability of the proposed formulation of PERSANTIN®
      compared to the present commercial formulation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration time curve from 48 to 58 hours (AUC48-58)
time frame: 48 - 58 hours
measure: Maximum concentration from 48 to 58 hours (Cmax48-58)
time frame: 48 - 58 hours
measure: Peak trough fluctuation (% PTF)
time frame: up to 48 hours
measure: Minimum concentration from 48 to 58 hours (Cmin48-58)
time frame: 48 - 58 hours
measure: Cmax48-58/AUC48-58 ratio
time frame: 48 - 58 hours
measure: Time to maximum concentration from 48 to 58 hours (Tmax48-58)
time frame: up to 58 hours
measure: Amount excreted in urine (Ae)
time frame: up to 24 hours after drug administration
measure: Number of participants with adverse events
time frame: up to 8 days after last drug administration
measure: Number of participants with clinically significant findings in vital functions
time frame: up to 8 days after last drug administration
description: blood pressure, pulse rate
measure: Number of participants with clinically significant findings in ECG
time frame: up to 8 days after last drug administration
measure: Number of participants with clinically significant findings in laboratory tests
time frame: up to 8 days after last drug administration
arm group label: Persantin® new formulation
arm group type: Experimental
arm group label: Persantin® commercial formulation
arm group type: Active Comparator
intervention type: Drug
intervention name: Persantin® new formulation
arm group label: Persantin® new formulation
intervention type: Drug
intervention name: Persantin® commercial formulation
arm group label: Persantin® commercial formulation
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Dipyridamole