<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/NCT02264197</url>
  </required_header>
  <id_info>
    <org_study_id>537.7</org_study_id>
    <nct_id>NCT02264197</nct_id>
  </id_info>
  <brief_title>Investigation of Pharmacokinetics of BIBX 245 CL and Safety in Healthy Subjects</brief_title>
  <official_title>Single-dose Pharmacokinetics of 160 mg BIBX 245 CL and Effect of Food After Oral Administration of Tablets to Healthy Subjects (Randomized, 2-way-cross-over, Open 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>
      Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food&#xD;
      on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 1998</start_date>
  <primary_completion_date type="Actual">June 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>Cmax (Maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 24 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 24 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>tmax (Time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 24 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>λz (Terminal rate constant in plasma)</measure>
    <time_frame>up to 24 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>t½ (Terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 24 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>MRTtot (Mean residence time)</measure>
    <time_frame>up to 24 hours post dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 20 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator</measure>
    <time_frame>after 20 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIBX 245 CL - fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>after a light breakfast with 40 g fat</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBX 245 CL - fasted</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBX 245 CL - fed</intervention_name>
    <arm_group_label>BIBX 245 CL - fed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBX 245 CL- fasted</intervention_name>
    <arm_group_label>BIBX 245 CL - fasted</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent in accordance with Good Clinical Practice (GCP) and local&#xD;
             legislation&#xD;
&#xD;
          -  Age &gt;= 18 and &lt;= 50 years&#xD;
&#xD;
          -  Broca &gt;= -20% and &lt;= +20%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding 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 gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurologic 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) (&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 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;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation &gt; 100 ml (&lt;= 4 weeks prior to administration or during the trial)&#xD;
&#xD;
          -  Excessive physical activities (&lt;= 10 days prior to administration or during the trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range or clinical relevance&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 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 14, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 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/NCT02264197
org study id: 537.7
nct id: NCT02264197
lead sponsor: 
Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food
      on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax (Maximum measured concentration of the analyte in plasma)
time frame: up to 24 hours post dose
measure: AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 24 hours post dose
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 24 hours post dose
measure: λz (Terminal rate constant in plasma)
time frame: up to 24 hours post dose
measure: t½ (Terminal half-life of the analyte in plasma)
time frame: up to 24 hours post dose
measure: MRTtot (Mean residence time)
time frame: up to 24 hours post dose
measure: Number of subjects with adverse events
time frame: up to 20 days
measure: Assessment of tolerability by investigator
time frame: after 20 days
arm group label: BIBX 245 CL - fed
arm group type: Experimental
description: after a light breakfast with 40 g fat
arm group label: BIBX 245 CL - fasted
arm group type: Active Comparator
intervention type: Drug
intervention name: BIBX 245 CL - fed
arm group label: BIBX 245 CL - fed
intervention type: Drug
intervention name: BIBX 245 CL- fasted
arm group label: BIBX 245 CL - fasted
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor