<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/NCT02262624</url>
  </required_header>
  <id_info>
    <org_study_id>502.438</org_study_id>
    <nct_id>NCT02262624</nct_id>
  </id_info>
  <brief_title>Bioequivalence of Telmisartan / HCTZ Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers</brief_title>
  <official_title>Bioequivalence of 80 mg Telmisartan/12.5 mg HCTZ of Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers (an Open-label, Randomised, Single-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>
      To establish the bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination vs.&#xD;
      its monocomponents&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2005</start_date>
  <primary_completion_date type="Actual">February 2005</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-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_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 after 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 after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant of the analyte in plasma)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of the analyte in the body after po administration)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in physical examination</measure>
    <time_frame>Up to 9 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in vital signs</measure>
    <time_frame>Up to 9 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in 12-lead ECG (electrocardiogram)</measure>
    <time_frame>Up to 9 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in laboratory parameters</measure>
    <time_frame>Up to 9 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Up to 9 days after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan/HCTZ fixed combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan and HCTZ monocomponents</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 and HCTZ monocomponents</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrochlorthiazide (HCTZ)</intervention_name>
    <arm_group_label>Telmisartan and HCTZ monocomponents</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan/HCTZ fixed combination</intervention_name>
    <arm_group_label>Telmisartan/HCTZ fixed combination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males according to the following criteria:&#xD;
&#xD;
             Based upon a complete medical history, physical finding, physical examination&#xD;
             (measurements of height and body weight), vital signs (blood pressure (BP), pulse rate&#xD;
             (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests 1) No finding of&#xD;
             clinical relevance 2) No evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          2. Age ≥ 20 years and age ≤ 35 years&#xD;
&#xD;
          3. Body Mass Index (BMI) ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2&#xD;
&#xD;
          4. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice (GCP) (MHW Ordinance No. 28, as of Mar. 27,&#xD;
             1997) 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. Positive result for Hepatitis B virus surface antigen (HBsAg), anti HCV (Hepatitis C&#xD;
             virus), syphilitic test or Human immunodeficiency virus (HIV) antigen-antibody test&#xD;
&#xD;
          8. Intake of drugs with a long half-life (≥ 24 hours) within at least 1 month prior to&#xD;
             administration or within a period of 10 or less half-lives of the respective drugs&#xD;
             during the trial&#xD;
&#xD;
          9. 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;
         10. Participation in another trial with an investigational drug within 4 months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
         11. Smoker (20 or more cigarettes/day)&#xD;
&#xD;
         12. Inability to refrain from smoking during hospitalisation&#xD;
&#xD;
         13. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous&#xD;
             (equivalent to 540 mL) of sake)&#xD;
&#xD;
         14. Drug abuse&#xD;
&#xD;
         15. Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
         16. Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
         17. Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
         18. Inability to comply with dietary regimen of study centre&#xD;
&#xD;
         19. Any other volunteers whom, the investigator or sub investigator would not allow to&#xD;
             participate in this study&#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 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>Hydrochlorothiazide</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/NCT02262624
org study id: 502.438
nct id: NCT02262624
lead sponsor: 
To establish the bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination vs.
      its monocomponents
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
time frame: Up to 72 hours after drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: Up to 72 hours after drug administration
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 after drug administration
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
time frame: Up to 72 hours after drug administration
measure: λz (terminal rate constant of the analyte in plasma)
time frame: Up to 72 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: Up to 72 hours after drug administration
measure: MRTpo (mean residence time of the analyte in the body after po administration)
time frame: Up to 72 hours after drug administration
measure: Number of participants with clinically significant findings in physical examination
time frame: Up to 9 days after last drug administration
measure: Number of participants with clinically significant findings in vital signs
time frame: Up to 9 days after last drug administration
measure: Number of participants with clinically significant findings in 12-lead ECG (electrocardiogram)
time frame: Up to 9 days after last drug administration
measure: Number of participants with clinically significant findings in laboratory parameters
time frame: Up to 9 days after last drug administration
measure: Number of participants with adverse events
time frame: Up to 9 days after last drug administration
arm group label: Telmisartan/HCTZ fixed combination
arm group type: Experimental
arm group label: Telmisartan and HCTZ monocomponents
arm group type: Active Comparator
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan and HCTZ monocomponents
intervention type: Drug
intervention name: Hydrochlorthiazide (HCTZ)
arm group label: Telmisartan and HCTZ monocomponents
intervention type: Drug
intervention name: Telmisartan/HCTZ fixed combination
arm group label: Telmisartan/HCTZ fixed combination
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
mesh term: Hydrochlorothiazide