<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/NCT02262559</url>
  </required_header>
  <id_info>
    <org_study_id>502.414</org_study_id>
    <nct_id>NCT02262559</nct_id>
  </id_info>
  <brief_title>Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers</brief_title>
  <official_title>Bioequivalence Study of BIBR 277 Tablet (Erythritol Based) Compared With Its Capsule Formation in Healthy Male Volunteers</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 bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277&#xD;
      capsule&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2002</start_date>
  <primary_completion_date type="Actual">August 2002</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 observed concentration of the Telmisartan in plasma)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Individual time courses of the Telmisartan plasma concentrations</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time to reach Cmax)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the Telmisartan in plasma)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT0-∞ (total mean residence time of Telmisartan molecules in the body)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 72 hours 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 72 hours after last drug administration</time_frame>
    <description>blood pressure, pulse rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 72 hours 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 72 hours after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIBR 277 tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBR 277 capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBR 277 tablet</intervention_name>
    <arm_group_label>BIBR 277 tablet</arm_group_label>
    <other_name>Telmisartan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBR 277 capsule</intervention_name>
    <arm_group_label>BIBR 277 capsule</arm_group_label>
    <other_name>Telmisartan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;= 20 and &lt;= 35 years&#xD;
&#xD;
          2. Weight: BMI &gt;= 17.6 and &lt;= 26.4 (Weight (kg) / Height (m)2)&#xD;
&#xD;
          3. Subjects judged by the investigator to be eligible as study subjects, with no&#xD;
             clinically significant findings after screening&#xD;
&#xD;
          4. Subjects who volunteer to participate and are able to fully understand and agree with&#xD;
             this study by written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          3. Chronic or relevant acute infections&#xD;
&#xD;
          4. History of hepatic disorder (e.g., biliary cirrhosis, cholestasis)&#xD;
&#xD;
          5. History of serious renal disorder&#xD;
&#xD;
          6. History of or present bilateral renal artery stenosis or lack of unilateral kidney&#xD;
             accompanying arterial stenosis&#xD;
&#xD;
          7. History of or present cerebrovascular disorder&#xD;
&#xD;
          8. History of hyperkalemia&#xD;
&#xD;
          9. History of hypersensitivity to active ingredient (Telmisartan) or other angiotensin II&#xD;
             receptor antagonists&#xD;
&#xD;
         10. History of or present orthostatic hypotension or faint&#xD;
&#xD;
         11. Surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
         12. History of alcohol or drug abuse&#xD;
&#xD;
         13. Participation to another trial with an investigational drug within 4 months prior to&#xD;
             the trial&#xD;
&#xD;
         14. Whole blood donation more than 400 mL within 3 months prior to the trial&#xD;
&#xD;
         15. Whole blood donation more than 100 mL within 1 month prior to the trial&#xD;
&#xD;
         16. Donation of constituent of blood of more than 400 mL within 1 month prior to the trial&#xD;
&#xD;
         17. Any medication which might influence the result of the trial within 10 days prior to&#xD;
             the trial&#xD;
&#xD;
         18. Excessive physical activities within 7 days prior to the trial&#xD;
&#xD;
         19. Alcohol drinking within 3 days prior to the trial&#xD;
&#xD;
         20. Inability to comply with restriction of protocol&#xD;
&#xD;
         21. Other than above, those who are judged by the investigator to be inappropriate as the&#xD;
             subjects of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 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 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 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/NCT02262559
org study id: 502.414
nct id: NCT02262559
lead sponsor: 
Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277
      capsule
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax (maximum observed concentration of the Telmisartan in plasma)
time frame: up to 72 hours after drug administration
measure: AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr
time frame: up to 72 hours after drug administration
measure: Individual time courses of the Telmisartan plasma concentrations
time frame: up to 72 hours after drug administration
measure: tmax (time to reach Cmax)
time frame: up to 72 hours after drug administration
measure: t1/2 (terminal half-life of the Telmisartan in plasma)
time frame: up to 72 hours after drug administration
measure: AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity)
time frame: up to 72 hours after drug administration
measure: MRT0-∞ (total mean residence time of Telmisartan molecules in the body)
time frame: up to 72 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 72 hours after last drug administration
measure: Number of subjects with clinically significant findings in vital signs
time frame: up to 72 hours after last drug administration
description: blood pressure, pulse rate
measure: Number of subjects with clinically significant findings in laboratory tests
time frame: up to 72 hours after last drug administration
measure: Number of subjects with clinically significant findings in ECG
time frame: up to 72 hours after last drug administration
arm group label: BIBR 277 tablet
arm group type: Experimental
arm group label: BIBR 277 capsule
arm group type: Active Comparator
intervention type: Drug
intervention name: BIBR 277 tablet
arm group label: BIBR 277 tablet
other name: Telmisartan
intervention type: Drug
intervention name: BIBR 277 capsule
arm group label: BIBR 277 capsule
other name: Telmisartan
criteria: 
gender: All
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Telmisartan