<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/NCT02183337</url>
  </required_header>
  <id_info>
    <org_study_id>1218.13</org_study_id>
    <nct_id>NCT02183337</nct_id>
  </id_info>
  <brief_title>Bioavailability of BI 1356 With and Without Co-administration of Pioglitazone and the Bioavailability of Pioglitazone With and Without Coadministration of BI 1356 in Healthy Male and Female Volunteers</brief_title>
  <official_title>Relative Bioavailability of Both BI 1356 and Pioglitazone After Co-administration Compared to the Bioavailability of Multiple Oral Doses of BI 1356 10 mg qd Alone and Pioglitazone 45 mg qd Alone in Healthy Male and Female Volunteers (an Open Label, Randomised, Multiple-dose, Two-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 bioavailability of BI 1356 with and without co-administration of&#xD;
      pioglitazone and the bioavailability of pioglitazone with and without coadministration of BI&#xD;
      1356&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2007</start_date>
  <primary_completion_date type="Actual">April 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>AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)</measure>
    <time_frame>up to 21 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)</measure>
    <time_frame>up to 21 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)</measure>
    <time_frame>up to 21 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C24,ss (concentration of the analyte in plasma at steady state after administration of the last dose at the end of the dosing interval)</measure>
    <time_frame>up to 21 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz,ss (terminal rate constant in plasma at steady state)</measure>
    <time_frame>up to 21 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2,ss (terminal half-life of the analyte in plasma at steady state)</measure>
    <time_frame>up to 21 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)</measure>
    <time_frame>up to 21 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)</measure>
    <time_frame>up to 21 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)</measure>
    <time_frame>up to 21 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in physical examination (including body weight)</measure>
    <time_frame>up to 27 days after last administration of study medication</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Vital signs (Blood pressure (BP), Pulse Rate (PR)</measure>
    <time_frame>up to 27 days after last administration of study medication</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in 12-lead ECG (electrocardiogram)</measure>
    <time_frame>up to 27 days after last administration of study medication</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in clinical laboratory values</measure>
    <time_frame>up to 27 days after last administration of study medication</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 27 days after last administration of study medication</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>up to 27 days after last administration of study medication</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 1356</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment sequence AB_C or C_AB&#xD;
Treatment A: 5 days BI 1356 until steady state followed by&#xD;
Treatment B: combined treatment of BI 1356 with pioglitazone for 7 days&#xD;
Treatment C: 7 days of treatment with Pioglitazone alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pioglitazone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment sequence AB_C or C_AB&#xD;
Treatment A: 5 days BI 1356 until steady state followed by&#xD;
Treatment B: combined treatment of BI 1356 with pioglitazone for 7 days&#xD;
Treatment C: 7 days of treatment with Pioglitazone alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1356</intervention_name>
    <arm_group_label>BI 1356</arm_group_label>
    <arm_group_label>Pioglitazone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1356 + Pioglitazone</intervention_name>
    <arm_group_label>BI 1356</arm_group_label>
    <arm_group_label>Pioglitazone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pioglitazone</intervention_name>
    <arm_group_label>BI 1356</arm_group_label>
    <arm_group_label>Pioglitazone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy females and males 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;
          -  Age ≥18 and Age ≤65 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;
          -  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 (e.g. HIV)&#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 (TdP) (e.g., heart&#xD;
             failure, hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
        For male subjects:&#xD;
&#xD;
          -  Not willing to use adequate contraception (condom use plus another form of&#xD;
             contraception e.g. spermicide, oral contraceptive taken by female partner,&#xD;
             sterilisation, IUD [intrauterine device]) during the whole study period from the time&#xD;
             of the first intake of study drug until one month after the last intake&#xD;
&#xD;
        For female subjects:&#xD;
&#xD;
          -  Pregnancy or planning to become pregnant within 2 months of study completion&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  Are not willing or are unable to use a reliable method of contraception (such as&#xD;
             implants, injectibles and combined oral contraceptives, sterilisation, IUD, double&#xD;
             barrier method) for at least 3 months prior to participation in the trial, during and&#xD;
             up to 2 months after completion/termination of the trial&#xD;
&#xD;
          -  Chronic use of oral contraception or hormone replacement containing ethinyl estradiol&#xD;
             as the only method of contraception&#xD;
&#xD;
          -  Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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/1218/1218.13_U07-1996.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>Pioglitazone</mesh_term>
    <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/NCT02183337
org study id: 1218.13
nct id: NCT02183337
lead sponsor: 
Study to investigate the bioavailability of BI 1356 with and without co-administration of
      pioglitazone and the bioavailability of pioglitazone with and without coadministration of BI
      1356
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
time frame: up to 21 days
measure: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
time frame: up to 21 days
measure: tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
time frame: up to 21 days
measure: C24,ss (concentration of the analyte in plasma at steady state after administration of the last dose at the end of the dosing interval)
time frame: up to 21 days
measure: λz,ss (terminal rate constant in plasma at steady state)
time frame: up to 21 days
measure: t1/2,ss (terminal half-life of the analyte in plasma at steady state)
time frame: up to 21 days
measure: MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
time frame: up to 21 days
measure: CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
time frame: up to 21 days
measure: Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
time frame: up to 21 days
measure: Changes in physical examination (including body weight)
time frame: up to 27 days after last administration of study medication
measure: Changes in Vital signs (Blood pressure (BP), Pulse Rate (PR)
time frame: up to 27 days after last administration of study medication
measure: Changes in 12-lead ECG (electrocardiogram)
time frame: up to 27 days after last administration of study medication
measure: Changes in clinical laboratory values
time frame: up to 27 days after last administration of study medication
measure: Number of patients with adverse events
time frame: up to 27 days after last administration of study medication
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: up to 27 days after last administration of study medication
arm group label: BI 1356
arm group type: Experimental
description: Treatment sequence AB_C or C_AB
Treatment A: 5 days BI 1356 until steady state followed by
Treatment B: combined treatment of BI 1356 with pioglitazone for 7 days
Treatment C: 7 days of treatment with Pioglitazone alone
arm group label: Pioglitazone
arm group type: Active Comparator
description: Treatment sequence AB_C or C_AB
Treatment A: 5 days BI 1356 until steady state followed by
Treatment B: combined treatment of BI 1356 with pioglitazone for 7 days
Treatment C: 7 days of treatment with Pioglitazone alone
intervention type: Drug
intervention name: BI 1356
arm group label: BI 1356
arm group label: Pioglitazone
intervention type: Drug
intervention name: BI 1356 + Pioglitazone
arm group label: BI 1356
arm group label: Pioglitazone
intervention type: Drug
intervention name: Pioglitazone
arm group label: BI 1356
arm group label: Pioglitazone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.13_U07-1996.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Pioglitazone
mesh term: Linagliptin