<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/NCT02262793</url>
  </required_header>
  <id_info>
    <org_study_id>502.458</org_study_id>
    <nct_id>NCT02262793</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability of Telmisartan and Dipyridamole After Co-administration Compared to the Bioavailability of Telmisartan or Dipyridamole Alone in Healthy Female and Male Subjects</brief_title>
  <official_title>Relative Bioavailability of Telmisartan in Micardis® and of Dipyridamole in Aggrenox® After Co-administration Compared to the Bioavailability of Telmisartan Respectively of Dipyridamole After Oral Administration of 80 mg Telmisartan Respectively of 25 mg ASA/200 mg Extended-release Dipyridamole Alone. An Open-label, Randomised, Single-dose, Four-way Crossover Study in 24 Healthy Female and Male 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>
      To investigate the relative bioavailability of telmisartan respectively of dipyridamole after&#xD;
      concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid&#xD;
      (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP&#xD;
      in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone&#xD;
      (Reference 2).&#xD;
&#xD;
      To investigate the relative bioavailability of dipyridamole respectively of telmisartan&#xD;
      administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2)&#xD;
      relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to&#xD;
      telmisartan in Micardis® alone (Reference 2).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2004</start_date>
  <primary_completion_date type="Actual">July 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 in plasma from 0 extrapolated to infinity)</measure>
    <time_frame>up to 72 hours following drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum concentration in plasma)</measure>
    <time_frame>up to 72 hours following drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>up to 72 hours following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt1-t2 (Area under the concentration time curve in plasma over the time interval t1 to t2)</measure>
    <time_frame>up to 72 hours following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of the analytes in plasma)</measure>
    <time_frame>up to 72 hours following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 72 hours following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analytes in plasma)</measure>
    <time_frame>up to 72 hours following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of the analyte in the body after p.o. administration)</measure>
    <time_frame>up to 72 hours following drug administration</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 following 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 72 hours following drug administration</time_frame>
  </secondary_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>
    <description>blood pressure, heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in 12 lead 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 laboratory tests</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by the investigator on a 4-point scale</measure>
    <time_frame>up to 8 days after last drug administration</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 and ASA/ER-DP (concomitant)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>ASA/ER-DP alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>telmisartan and ASA/ER-DP (consecutively)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>telmisartan</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</arm_group_label>
    <arm_group_label>telmisartan and ASA/ER-DP (concomitant)</arm_group_label>
    <arm_group_label>telmisartan and ASA/ER-DP (consecutively)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASA/ER-DP</intervention_name>
    <arm_group_label>ASA/ER-DP alone</arm_group_label>
    <arm_group_label>telmisartan and ASA/ER-DP (concomitant)</arm_group_label>
    <arm_group_label>telmisartan and ASA/ER-DP (consecutively)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy females and males according to the following criteria:&#xD;
&#xD;
             Based upon a complete medical history, including the physical examination, vital signs&#xD;
             (BP, HR), 12-lead ECG, clinical laboratory tests&#xD;
&#xD;
               -  No finding deviating from normal and of clinical relevance&#xD;
&#xD;
               -  No evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          2. Age ≥21 and Age ≤65 years&#xD;
&#xD;
          3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)&#xD;
&#xD;
          4. 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;
          1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          2. Surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          4. History of relevant orthostatic hypotension, fainting spells or blackouts.&#xD;
&#xD;
          5. Chronic or relevant acute infections&#xD;
&#xD;
          6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          7. 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;
          8. 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;
          9. Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
         10. Smoker (more than 10 cigarettes/day or 3 cigars/day or 3 pipes/day)&#xD;
&#xD;
         11. Inability to refrain from smoking on trial days&#xD;
&#xD;
         12. Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
         13. Drug abuse&#xD;
&#xD;
         14. Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
         15. Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
         16. Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
         17. Inability to comply with dietary regimen of study centre&#xD;
&#xD;
         18. History of hereditary fructose intolerance&#xD;
&#xD;
         19. History of any familial bleeding disorder&#xD;
&#xD;
         20. 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;
         21. Inability to comply with the investigators instructions&#xD;
&#xD;
             For female subjects:&#xD;
&#xD;
         22. Pregnancy&#xD;
&#xD;
         23. Positive pregnancy test&#xD;
&#xD;
         24. No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device&#xD;
             (IUD)&#xD;
&#xD;
         25. Inability to maintain this adequate contraception during the whole study period&#xD;
&#xD;
         26. Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 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 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>
  </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/NCT02262793
org study id: 502.458
nct id: NCT02262793
lead sponsor: 
To investigate the relative bioavailability of telmisartan respectively of dipyridamole after
      concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid
      (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP
      in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone
      (Reference 2).

      To investigate the relative bioavailability of dipyridamole respectively of telmisartan
      administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2)
      relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to
      telmisartan in Micardis® alone (Reference 2).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-∞ (area under the concentration time curve in plasma from 0 extrapolated to infinity)
time frame: up to 72 hours following drug administration
measure: Cmax (maximum concentration in plasma)
time frame: up to 72 hours following drug administration
measure: AUC0-tz (area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: up to 72 hours following drug administration
measure: AUCt1-t2 (Area under the concentration time curve in plasma over the time interval t1 to t2)
time frame: up to 72 hours following drug administration
measure: tmax (time from dosing to the maximum concentration of the analytes in plasma)
time frame: up to 72 hours following drug administration
measure: λz (terminal rate constant in plasma)
time frame: up to 72 hours following drug administration
measure: t1/2 (terminal half-life of the analytes in plasma)
time frame: up to 72 hours following drug administration
measure: MRTpo (mean residence time of the analyte in the body after p.o. administration)
time frame: up to 72 hours following drug administration
measure: CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
time frame: up to 72 hours following drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: up to 72 hours following drug administration
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
description: blood pressure, heart rate
measure: Number of subjects with clinically significant findings in 12 lead ECG
time frame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
time frame: up to 8 days after last drug administration
measure: Assessment of tolerability by the investigator on a 4-point scale
time frame: up to 8 days after last drug administration
arm group label: telmisartan and ASA/ER-DP (concomitant)
arm group type: Experimental
arm group label: ASA/ER-DP alone
arm group type: Active Comparator
arm group label: telmisartan and ASA/ER-DP (consecutively)
arm group type: Experimental
arm group label: telmisartan
arm group type: Active Comparator
intervention type: Drug
intervention name: telmisartan
arm group label: telmisartan
arm group label: telmisartan and ASA/ER-DP (concomitant)
arm group label: telmisartan and ASA/ER-DP (consecutively)
intervention type: Drug
intervention name: ASA/ER-DP
arm group label: ASA/ER-DP alone
arm group label: telmisartan and ASA/ER-DP (concomitant)
arm group label: telmisartan and ASA/ER-DP (consecutively)
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Telmisartan