<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/NCT02261129</url>
  </required_header>
  <id_info>
    <org_study_id>502.557</org_study_id>
    <nct_id>NCT02261129</nct_id>
  </id_info>
  <brief_title>Bioequivalence of Telmisartan Film-coated Tablet Compared With Two Tablets of the Conventional Telmisartan Tablet in Healthy Male Volunteers</brief_title>
  <official_title>Bioequivalence of the 80 mg Telmisartan Film-coated Tablet Compared With Two Tablets of the Conventional 40 mg Telmisartan Tablet Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated 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 demonstrate the bioequivalence of the telmisartan 80 mg film-coated tablet vs. two&#xD;
      tablets of the telmisartan 40 mg conventional tablet&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <primary_completion_date type="Actual">December 2008</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>Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable data point (AUC0-tz)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to the maximum measured concentration of the analyte in plasma (tmax)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant of the analyte in plasma (λz)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of the analyte in plasma (t1/2)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean residence time of the analyte in the body after po administration (MRTpo)</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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan, film-coated tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one tablet of telmisartan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan, conventional tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Two tablets of telmisartan</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan film-coated tablet</intervention_name>
    <arm_group_label>Telmisartan, film-coated tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan uncoated tablet</intervention_name>
    <arm_group_label>Telmisartan, conventional tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy Japanese males according to the following criteria:&#xD;
&#xD;
             Based upon a complete medical history, including the physical examination, vital signs&#xD;
             (Blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests&#xD;
&#xD;
               -  1.1 No findings deviating from normal and of clinical relevance&#xD;
&#xD;
               -  1.2 No evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          2. Age ≥20 and ≤35 years&#xD;
&#xD;
          3. Body weight≥50kg&#xD;
&#xD;
          4. Body Mass Index ≥18.0 and ≤25.0 kg/m2&#xD;
&#xD;
          5. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any finding of the medical examination (including blood pressure, pulse rate, body&#xD;
             temperature, and ECG) deviating from normal and of clinical relevance&#xD;
&#xD;
          2. Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological, or hormonal disorders&#xD;
&#xD;
          4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          5. Chronic or relevant acute infections&#xD;
&#xD;
          6. History of relevant allergy/hypersensitivity (including allergy to a drug or its&#xD;
             excipients)&#xD;
&#xD;
          7. Any clinical relevant findings of the laboratory test deviating from normal&#xD;
&#xD;
          8. Positive result for either hepatitis B antigen, anti hepatitis C virus antibodies,&#xD;
             syphilitic test or human immunodeficiency virus (HIV) test&#xD;
&#xD;
          9. History of surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
         10. History of relevant orthostatic hypotension (mean standing systolic blood pressure&#xD;
             (SBP) varies by ≥20 mmHg from mean supine SBP or mean standing diastolic blood&#xD;
             pressure (DBP) varies by ≥10 mmHg from mean supine DBP), fainting spells or blackouts&#xD;
&#xD;
         11. History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis)&#xD;
&#xD;
         12. History of serious renal dysfunction&#xD;
&#xD;
         13. History of bilateral renal artery stenosis or renal artery stenosis in a solitary&#xD;
             kidney&#xD;
&#xD;
         14. History of cerebrovascular disorder&#xD;
&#xD;
         15. History of hyperkalemia&#xD;
&#xD;
         16. Known hypersensitivity to any component of the telmisartan formulation, or to any&#xD;
             other angiotensin II receptor blockers&#xD;
&#xD;
         17. Intake of drugs with a long half-life (≥24 hours) within at least one month or less&#xD;
             than 10 half-lives of the respective drug before administration of the investigational&#xD;
             product&#xD;
&#xD;
         18. Use of any drugs within 10 days before administration of the investigational product&#xD;
             or during the trial&#xD;
&#xD;
         19. Participation in another trial with an investigational drug within four months before&#xD;
             administration of the investigational product or during the trial&#xD;
&#xD;
         20. Smoker (&gt;10 cigarettes or &gt;3 cigars or &gt;3 pipes/day)&#xD;
&#xD;
         21. Alcohol abuse&#xD;
&#xD;
         22. Drug abuse&#xD;
&#xD;
         23. Blood donation (100 mL or more) within four weeks before administration of the&#xD;
             investigational product&#xD;
&#xD;
         24. Excessive physical activities within one week before administration of the&#xD;
             investigational product or during the trial&#xD;
&#xD;
         25. Intake of alcohol within 2 days prior to administration&#xD;
&#xD;
         26. Inability to comply with dietary regimen of study centre&#xD;
&#xD;
         27. Inability to refrain from smoking on trial days&#xD;
&#xD;
         28. Any other clinical conditions that investigator or sub-investigator judges that the&#xD;
             subject is ineligible for study participation&#xD;
      </textblock>
    </criteria>
    <gender>Male</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 10, 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 10, 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/NCT02261129
org study id: 502.557
nct id: NCT02261129
lead sponsor: 
Study to demonstrate the bioequivalence of the telmisartan 80 mg film-coated tablet vs. two
      tablets of the telmisartan 40 mg conventional tablet
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable data point (AUC0-tz)
time frame: up to 72 hours after drug administration
measure: Maximum measured concentration of the analyte in plasma (Cmax)
time frame: up to 72 hours after drug administration
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
time frame: up to 72 hours after drug administration
measure: Time from dosing to the maximum measured concentration of the analyte in plasma (tmax)
time frame: up to 72 hours after drug administration
measure: Terminal rate constant of the analyte in plasma (λz)
time frame: up to 72 hours after drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
time frame: up to 72 hours after drug administration
measure: mean residence time of the analyte in the body after po administration (MRTpo)
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
arm group label: Telmisartan, film-coated tablet
arm group type: Experimental
description: one tablet of telmisartan
arm group label: Telmisartan, conventional tablet
arm group type: Active Comparator
description: Two tablets of telmisartan
intervention type: Drug
intervention name: Telmisartan film-coated tablet
arm group label: Telmisartan, film-coated tablet
intervention type: Drug
intervention name: Telmisartan uncoated tablet
arm group label: Telmisartan, conventional tablet
criteria: 
gender: Male
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