<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/NCT02183363</url>
  </required_header>
  <id_info>
    <org_study_id>1218.25</org_study_id>
    <nct_id>NCT02183363</nct_id>
  </id_info>
  <brief_title>Bioavailability of BI 1356 After Single Oral Administration Given as Different Tablet Formulation in Healthy Male Volunteers</brief_title>
  <official_title>Bioavailability of BI 1356 After Single Oral Administration of 5 mg BI 1356 Given as Tablet Formulation TF IIb Relative to Tablet Formulation TF II and Tablet Formulation iFF in Healthy Male Volunteers (an Open Label, Randomised, Single-dose, Three-way Crossover 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>
      Study to investigate the relative bioavailability of 5 mg BI 1356 as tablet formulations&#xD;
      (Trial formulation) TF II and Intended final formulation (iFF) vs. 5 mg BI 1356 as tablet TF&#xD;
      IIb&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2007</start_date>
  <primary_completion_date type="Actual">May 2007</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>AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)</measure>
    <time_frame>predose, up to 24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>predose, up to 264 hours</time_frame>
  </secondary_outcome>
  <secondary_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>predose, up to 264 hours</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>predose, up to 264 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt1-t2 (Partial area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)</measure>
    <time_frame>predose, up to 264 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C24 (plasma concentration of the analyte 24 hours after dosing)</measure>
    <time_frame>predose, up to 264 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>predose, up to 264 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>predose, up to 264 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>predose, up to 264 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of the analyte in the body after po administration)</measure>
    <time_frame>predose, up to 264 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of the analyte in the plasma after extravascular administration)</measure>
    <time_frame>predose, up to 264 hours</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>predose, up to 264 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Dipeptidyl-peptidase-IV (DPP-IV) activity in plasma</measure>
    <time_frame>predose, up to 264 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma glucose levels</measure>
    <time_frame>predose, up to 264 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 18 days following last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal findings in physical examination</measure>
    <time_frame>up to 18 days following last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))</measure>
    <time_frame>up to 18 days following last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes 12-lead ECG (electrocardiogram)</measure>
    <time_frame>up to 18 days following last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 18 days following last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>up to 18 days following last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 1356 - Tablet TFII</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 1356 - Tablet iFF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 1356 - Tablet TFIIb</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1356 - Tablet TFII</intervention_name>
    <arm_group_label>BI 1356 - Tablet TFII</arm_group_label>
    <arm_group_label>BI 1356 - Tablet TFIIb</arm_group_label>
    <arm_group_label>BI 1356 - Tablet iFF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1356 - Tablet iFF</intervention_name>
    <arm_group_label>BI 1356 - Tablet TFII</arm_group_label>
    <arm_group_label>BI 1356 - Tablet TFIIb</arm_group_label>
    <arm_group_label>BI 1356 - Tablet iFF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1356 - Tablet TFIIb</intervention_name>
    <arm_group_label>BI 1356 - Tablet TFII</arm_group_label>
    <arm_group_label>BI 1356 - Tablet TFIIb</arm_group_label>
    <arm_group_label>BI 1356 - Tablet iFF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects according to the following criteria: Based upon a complete&#xD;
             medical history, including the physical examination, vital signs, Blood Pressure (BP),&#xD;
             Pulse Rate (PR), 12-lead Electrocardiogram (ECG), clinical laboratory tests&#xD;
&#xD;
               -  No findings deviating from normal and of clinical relevance&#xD;
&#xD;
               -  No evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          -  Age ≥21 and Age ≤55 years&#xD;
&#xD;
          -  BMI ≥18.5 and BMI ≤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 (GCP) and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#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;
             neurological disorders&#xD;
&#xD;
          -  History of relevant 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 prior to administration or during the trial&#xD;
&#xD;
          -  Use of drugs which might reasonably influence the results of the trial based on the&#xD;
             knowledge at the time of protocol preparation within 10 days prior to administration&#xD;
             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 study centre&#xD;
      </textblock>
    </criteria>
    <gender>Male</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/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.25_U07-2003.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 4, 2014</last_update_submitted>
  <last_update_submitted_qc>July 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 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>Linagliptin</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/NCT02183363
org study id: 1218.25
nct id: NCT02183363
lead sponsor: 
Study to investigate the relative bioavailability of 5 mg BI 1356 as tablet formulations
      (Trial formulation) TF II and Intended final formulation (iFF) vs. 5 mg BI 1356 as tablet TF
      IIb
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)
time frame: predose, up to 24 hours
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: predose, up to 264 hours
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: predose, up to 264 hours
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: predose, up to 264 hours
measure: AUCt1-t2 (Partial area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
time frame: predose, up to 264 hours
measure: C24 (plasma concentration of the analyte 24 hours after dosing)
time frame: predose, up to 264 hours
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
time frame: predose, up to 264 hours
measure: λz (terminal rate constant in plasma)
time frame: predose, up to 264 hours
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: predose, up to 264 hours
measure: MRTpo (mean residence time of the analyte in the body after po administration)
time frame: predose, up to 264 hours
measure: CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
time frame: predose, up to 264 hours
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: predose, up to 264 hours
measure: Changes in Dipeptidyl-peptidase-IV (DPP-IV) activity in plasma
time frame: predose, up to 264 hours
measure: Changes in plasma glucose levels
time frame: predose, up to 264 hours
measure: Number of patients with adverse events
time frame: up to 18 days following last drug administration
measure: Number of patients with abnormal findings in physical examination
time frame: up to 18 days following last drug administration
measure: Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))
time frame: up to 18 days following last drug administration
measure: Number of patients with abnormal changes 12-lead ECG (electrocardiogram)
time frame: up to 18 days following last drug administration
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to 18 days following last drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: up to 18 days following last drug administration
arm group label: BI 1356 - Tablet TFII
arm group type: Experimental
arm group label: BI 1356 - Tablet iFF
arm group type: Experimental
arm group label: BI 1356 - Tablet TFIIb
arm group type: Active Comparator
intervention type: Drug
intervention name: BI 1356 - Tablet TFII
arm group label: BI 1356 - Tablet TFII
arm group label: BI 1356 - Tablet TFIIb
arm group label: BI 1356 - Tablet iFF
intervention type: Drug
intervention name: BI 1356 - Tablet iFF
arm group label: BI 1356 - Tablet TFII
arm group label: BI 1356 - Tablet TFIIb
arm group label: BI 1356 - Tablet iFF
intervention type: Drug
intervention name: BI 1356 - Tablet TFIIb
arm group label: BI 1356 - Tablet TFII
arm group label: BI 1356 - Tablet TFIIb
arm group label: BI 1356 - Tablet iFF
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.25_U07-2003.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Linagliptin