<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/NCT02223000</url>
  </required_header>
  <id_info>
    <org_study_id>528.22</org_study_id>
    <nct_id>NCT02223000</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability and Tolerability of Various Experimental Formulations of BIBV 308 SE in Healthy Subjects</brief_title>
  <official_title>Relative Bioavailability and Tolerability of Various Experimental Formulations of 50 mg BIBV 308 SE Administered Orally Twice a Day Over 3.5 Days to Healthy Subjects (Intraindividual Comparison, Open, Partially Randomised).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral&#xD;
      solution of BIBV 308 SE following multiple doses, tolerability&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 1998</start_date>
  <primary_completion_date type="Actual">July 1998</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 of the analyte in plasma at steady state (AUCss)</measure>
    <time_frame>up to 84 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)</measure>
    <time_frame>up to 84 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss)</measure>
    <time_frame>up to 84 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent peak-trough fluctuation (%PTF)</measure>
    <time_frame>up to 84 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)</measure>
    <time_frame>up to 84 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of the analyte in the body (MRTtot)</measure>
    <time_frame>up to 84 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of the analyte in plasma (CL/f)</measure>
    <time_frame>up to 84 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of Cmax,ss/AUCss</measure>
    <time_frame>up to 84 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough concentrations of BIBV 308 SE before doses</measure>
    <time_frame>up to day 4</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIBV 308 SE solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBV 308 SE capsule 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBV 308 SE capsule 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBV 308 SE solution</intervention_name>
    <arm_group_label>BIBV 308 SE solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBV 308 SE capsule 1</intervention_name>
    <arm_group_label>BIBV 308 SE capsule 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBV 308 SE capsule 2</intervention_name>
    <arm_group_label>BIBV 308 SE capsule 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects that were previously entered in at least one BIBV 308 SE study to ensure that&#xD;
             it is known how these subjects absorb BIBV 308 SE&#xD;
&#xD;
          -  Healthy subjects as determined by results of screening&#xD;
&#xD;
          -  Signed written informed consent in accordance with Good Clinical Practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age &gt;= 18 and &lt;= 55 years&#xD;
&#xD;
          -  Broca &gt;= -20% and &lt;= +20 %&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor individual absorption kinetics of BIBV 308 SE in previous studies&#xD;
&#xD;
          -  Any findings of the medical examination (including blood pressure, pulse rate and&#xD;
             Electrocardiogram (ECG)) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Surgery of the gastro-intestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  Hypersensitivity to BIBV 308 SE and any of the excipients&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) &lt;= 1 month prior to administration&#xD;
             or during the trial&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial &lt;= 10 days prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug &lt;= 2 months days 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 study days&#xD;
&#xD;
          -  Known alcohol or drug abuse&#xD;
&#xD;
          -  Blood donation &lt;= 1 month prior to administration&#xD;
&#xD;
          -  Excessive physical activities &lt;= 5 days prior to administration&#xD;
&#xD;
          -  History of hemorrhagic diathesis&#xD;
&#xD;
          -  History of gastro-intestinal ulcer, perforation or bleeding&#xD;
&#xD;
          -  History of bronchial asthma&#xD;
&#xD;
          -  Any laboratory value outside the reference range of clinical relevance&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 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/NCT02223000
org study id: 528.22
nct id: NCT02223000
lead sponsor: 
Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral
      solution of BIBV 308 SE following multiple doses, tolerability
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)
time frame: up to 84 hours after drug administration
measure: Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)
time frame: up to 84 hours after drug administration
measure: Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss)
time frame: up to 84 hours after drug administration
measure: Percent peak-trough fluctuation (%PTF)
time frame: up to 84 hours after drug administration
measure: Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
time frame: up to 84 hours after drug administration
measure: Mean residence time of the analyte in the body (MRTtot)
time frame: up to 84 hours after drug administration
measure: Apparent clearance of the analyte in plasma (CL/f)
time frame: up to 84 hours after drug administration
measure: Ratio of Cmax,ss/AUCss
time frame: up to 84 hours after drug administration
measure: Trough concentrations of BIBV 308 SE before doses
time frame: up to day 4
arm group label: BIBV 308 SE solution
arm group type: Active Comparator
arm group label: BIBV 308 SE capsule 1
arm group type: Experimental
arm group label: BIBV 308 SE capsule 2
arm group type: Experimental
intervention type: Drug
intervention name: BIBV 308 SE solution
arm group label: BIBV 308 SE solution
intervention type: Drug
intervention name: BIBV 308 SE capsule 1
arm group label: BIBV 308 SE capsule 1
intervention type: Drug
intervention name: BIBV 308 SE capsule 2
arm group label: BIBV 308 SE capsule 2
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor