<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/NCT02215746</url>
  </required_header>
  <id_info>
    <org_study_id>1246.2</org_study_id>
    <nct_id>NCT02215746</nct_id>
  </id_info>
  <brief_title>Bioavailability of BI 44370 TA Drinking Solution or Tablets With and Without a High Fat Meal in Healthy Male and Female Volunteers</brief_title>
  <official_title>Relative Oral Bioavailability of BI 44370 TA Drinking Solution (100 mg and 200 mg) and BI 44370 TA Tablets (100 mg as Two 50 mg Tablets) With and Without a High Fat Meal in Healthy Male and Female Volunteers: A Single Dose, Open-label, Randomised Six-way Cross-over Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objective of this trial was to evaluate the relative oral bioavailability and&#xD;
      pharmacokinetics of BI 44370 TA drinking solution (100 mg and 200 mg) and BI 44370 TA tablets&#xD;
      (100 mg as two 50 mg tablets) with and without a high fat meal and to assess the safety and&#xD;
      tolerability of the substances.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <primary_completion_date type="Actual">April 2008</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 concentration of the analyte in plasma)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-2 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 2 h after drug administration)</measure>
    <time_frame>up to 2 hours after drug administration</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 after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>tmax (time from dosing to maximum measured concentration)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt1-t2 (Area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTp.o. (mean residence time of the analyte in the body after p.o. administration)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant findings in vital signs (blood pressure and pulse rate)</measure>
    <time_frame>up to 11 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram)</measure>
    <time_frame>up to 11 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant laboratory findings</measure>
    <time_frame>up to 11 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 34 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>within 10 days after administration of study drug</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 44370 TA drinking solution 100 mg fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 44370 TA drinking solution 100 mg fed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 44370 TA drinking solution 200 mg fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 44370 TA drinking solution 200 mg fed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 mg BI 44370 BS as two tablets 50 mg fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 mg BI 44370 BS as two tablets 50 mg fed</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 44370 powder for oral solution</intervention_name>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_label>Treatment C</arm_group_label>
    <arm_group_label>Treatment D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 44370 tablet</intervention_name>
    <arm_group_label>Treatment E</arm_group_label>
    <arm_group_label>Treatment F</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high fat breakfast</intervention_name>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_label>Treatment D</arm_group_label>
    <arm_group_label>Treatment F</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female subjects according to the following criteria based upon a&#xD;
             complete medical history, including the physical examination, vital signs (BP, PR),&#xD;
             12-lead ECG, clinical laboratory tests&#xD;
&#xD;
          -  Age ≥21 and ≤55 years&#xD;
&#xD;
          -  BMI ≥18.5 and ≤29.9 kg/m2 (Body Mass Index)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including BP, PR, and ECG) deviating from&#xD;
             normal and of clinical relevance&#xD;
&#xD;
          -  Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Surgery of the gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of relevant allergy/hypersensitivity (including allergy to drug or its&#xD;
             excipients)&#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 prior to administration or during the trial&#xD;
&#xD;
          -  Use of drugs which might reasonably influence the results of the trial or that prolong&#xD;
             the QT/QTc interval based on the knowledge at the time of protocol preparation within&#xD;
             10 days prior to administration or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within 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 (more than 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
          -  Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
          -  A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a&#xD;
             QTc interval &gt;450 ms)&#xD;
&#xD;
          -  A history of additional risk factors for torsade de pointes (e.g., heart failure,&#xD;
             hypokalemia, family, history of Long QT Syndrome)&#xD;
&#xD;
        For Male Subjects:&#xD;
&#xD;
          -  Not willing to use adequate contraception (condoms use plus another form of&#xD;
             contraception e.g. spermicide, oral contraceptive taken by female partner,&#xD;
             sterilisation, intrauterine device) during the whole study period from the time of the&#xD;
             first intake of study drug until three months after the last intake&#xD;
&#xD;
        For Female Subjects:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  No adequate contraception (adequate contraception e.g. sterilisation, intrauterine&#xD;
             pessary (IUP), oral contraceptives)&#xD;
&#xD;
          -  Inability to maintain this adequate contraception during the whole study period during&#xD;
             the whole study period from the time of the first intake of study drug until one month&#xD;
             after the last intake&#xD;
&#xD;
          -  Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 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 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 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/NCT02215746
org study id: 1246.2
nct id: NCT02215746
lead sponsor: 
The objective of this trial was to evaluate the relative oral bioavailability and
      pharmacokinetics of BI 44370 TA drinking solution (100 mg and 200 mg) and BI 44370 TA tablets
      (100 mg as two 50 mg tablets) with and without a high fat meal and to assess the safety and
      tolerability of the substances.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax (maximum concentration of the analyte in plasma)
time frame: up to 24 hours after drug administration
measure: AUC0-2 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 2 h after drug administration)
time frame: up to 2 hours after drug administration
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 after drug administration
measure: tmax (time from dosing to maximum measured concentration)
time frame: up to 24 hours after drug administration
measure: %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
time frame: up to 24 hours after drug administration
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: up to 24 hours after drug administration
measure: AUCt1-t2 (Area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)
time frame: up to 24 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: up to 24 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 24 hours after drug administration
measure: MRTp.o. (mean residence time of the analyte in the body after p.o. administration)
time frame: up to 24 hours after drug administration
measure: CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
time frame: up to 24 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: up to 24 hours after drug administration
measure: Number of patients with clinically relevant findings in vital signs (blood pressure and pulse rate)
time frame: up to 11 days
measure: Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram)
time frame: up to 11 days
measure: Number of patients with clinically relevant laboratory findings
time frame: up to 11 days
measure: Number of patients with adverse events
time frame: up to 34 days
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: within 10 days after administration of study drug
arm group label: Treatment A
arm group type: Experimental
description: BI 44370 TA drinking solution 100 mg fasted
arm group label: Treatment B
arm group type: Experimental
description: BI 44370 TA drinking solution 100 mg fed
arm group label: Treatment C
arm group type: Experimental
description: BI 44370 TA drinking solution 200 mg fasted
arm group label: Treatment D
arm group type: Experimental
description: BI 44370 TA drinking solution 200 mg fed
arm group label: Treatment E
arm group type: Experimental
description: 100 mg BI 44370 BS as two tablets 50 mg fasted
arm group label: Treatment F
arm group type: Experimental
description: 100 mg BI 44370 BS as two tablets 50 mg fed
intervention type: Drug
intervention name: BI 44370 powder for oral solution
arm group label: Treatment A
arm group label: Treatment B
arm group label: Treatment C
arm group label: Treatment D
intervention type: Drug
intervention name: BI 44370 tablet
arm group label: Treatment E
arm group label: Treatment F
intervention type: Other
intervention name: high fat breakfast
arm group label: Treatment B
arm group label: Treatment D
arm group label: Treatment F
criteria: 
gender: All
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor