<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/NCT02262650</url>
  </required_header>
  <id_info>
    <org_study_id>502.457</org_study_id>
    <nct_id>NCT02262650</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability of Telmisartan and SR26334 After Co-administration Compared to the Bioavailability of Telmisartan and SR26334 After Administration of Telmisartan and Clopidogrel Alone in Healthy Male and Female Subjects</brief_title>
  <official_title>Relative Bioavailability of Telmisartan and SR26334, the Main Metabolite of Clopidogrel, After Co-administration Compared to the Bioavailability of Telmisartan and SR26334 After p.o. Administration of 80 mg Telmisartan and 75 mg Clopidogrel Alone. A Four-way, Single Dose, Open, Randomised Crossover Study in 24 Healthy Male and Female Subjects</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 concomitant administration of&#xD;
      clopidogrel and telmisartan (Test 1) relative to the bioavailability of SR26334 alone&#xD;
      (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2). And to&#xD;
      investigate the bioavailability of SR26334 following administration of clopidogrel 30 minutes&#xD;
      after intake of telmisartan (Test 2) relative to the bioavailability of SR26334 alone&#xD;
      (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2004</start_date>
  <primary_completion_date type="Actual">May 2004</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-∞ (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 72 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 72 hours post dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in vital signs</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in ECG</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in labortory test</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analytes in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>up to 72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analytes in plasma)</measure>
    <time_frame>up to 72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of the analytes in the body after po administration)</measure>
    <time_frame>up to 72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of the analytes in the plasma after extravascular administration)</measure>
    <time_frame>up to 72 hours post dose</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 72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLR, 0-24 (renal clearance of SR26334 in plasma from the time point t1 until the time point t2)</measure>
    <time_frame>up to 72 hours post dose</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan + Clopidogrel (concomitantly)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan + Clopidogrel (consecutively)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Clopidogrel alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Telmisartan + Clopidogrel (concomitantly)</arm_group_label>
    <arm_group_label>Telmisartan + Clopidogrel (consecutively)</arm_group_label>
    <arm_group_label>Telmisartan alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <arm_group_label>Clopidogrel alone</arm_group_label>
    <arm_group_label>Telmisartan + Clopidogrel (concomitantly)</arm_group_label>
    <arm_group_label>Telmisartan + Clopidogrel (consecutively)</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, the physical examination, vital signs (BP, HR), 12-lead ECG,&#xD;
             clinical laboratory tests&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice (GCP) and local legislation&#xD;
&#xD;
          -  Age &gt;= 40 years&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt;=18.5 and &lt;=29.9 kg/m2&#xD;
&#xD;
          -  Good venous status of forearms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, heart rate, and&#xD;
             electrocardiogram) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic&#xD;
             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 an allergy/hypersensitivity (including drug allergy) which is deemed&#xD;
             relevant 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 any drugs, which might reasonably influence the results of the trial based on&#xD;
             the knowledge at the time of protocol preparation within 10 days prior to&#xD;
             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 (more than 10 cigarettes or three cigars or three pipes/day)&#xD;
&#xD;
          -  Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation or loss of more than 400 mL within four weeks prior to administration&#xD;
             or during the trial.&#xD;
&#xD;
          -  Excessive physical activities (within five days prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range of clinical relevance&#xD;
&#xD;
          -  History of hereditary fructose intolerance&#xD;
&#xD;
          -  Veins unsuited for i.v. puncture on either arm (e.g. veins which are difficult to&#xD;
             locate, access or puncture, veins with a tendency to rupture during or after puncture,&#xD;
             etc.)&#xD;
&#xD;
          -  Inability to comply with the dietary regimen of study centre&#xD;
&#xD;
          -  Inability to comply with the investigators instructions&#xD;
&#xD;
        For female subjects:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device&#xD;
             (IUD)&#xD;
&#xD;
          -  Inability to maintain this adequate contraception during the whole study period&#xD;
&#xD;
          -  Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</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 10, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 10, 2014</last_update_submitted>
  <last_update_submitted_qc>October 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 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>Telmisartan</mesh_term>
    <mesh_term>Clopidogrel</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/NCT02262650
org study id: 502.457
nct id: NCT02262650
lead sponsor: 
Study to investigate the relative bioavailability of concomitant administration of
      clopidogrel and telmisartan (Test 1) relative to the bioavailability of SR26334 alone
      (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2). And to
      investigate the bioavailability of SR26334 following administration of clopidogrel 30 minutes
      after intake of telmisartan (Test 2) relative to the bioavailability of SR26334 alone
      (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2)
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
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 72 hours post dose
measure: Cmax (maximum concentration of the analyte in plasma)
time frame: up to 72 hours post dose
measure: Number of subjects with adverse events
time frame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in vital signs
time frame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in ECG
time frame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in labortory test
time frame: up to 8 days after last drug administration
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 72 hours post dose
measure: AUC0-tz (area under the concentration-time curve of the analytes in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: up to 72 hours post dose
measure: λz (terminal rate constant in plasma)
time frame: up to 72 hours post dose
measure: t1/2 (terminal half-life of the analytes in plasma)
time frame: up to 72 hours post dose
measure: MRTpo (mean residence time of the analytes in the body after po administration)
time frame: up to 72 hours post dose
measure: CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
time frame: up to 72 hours post dose
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: up to 72 hours post dose
measure: CLR, 0-24 (renal clearance of SR26334 in plasma from the time point t1 until the time point t2)
time frame: up to 72 hours post dose
arm group label: Telmisartan alone
arm group type: Active Comparator
arm group label: Telmisartan + Clopidogrel (concomitantly)
arm group type: Experimental
arm group label: Telmisartan + Clopidogrel (consecutively)
arm group type: Experimental
arm group label: Clopidogrel alone
arm group type: Active Comparator
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan + Clopidogrel (concomitantly)
arm group label: Telmisartan + Clopidogrel (consecutively)
arm group label: Telmisartan alone
intervention type: Drug
intervention name: Clopidogrel
arm group label: Clopidogrel alone
arm group label: Telmisartan + Clopidogrel (concomitantly)
arm group label: Telmisartan + Clopidogrel (consecutively)
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Telmisartan
mesh term: Clopidogrel