<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/NCT02259803</url>
  </required_header>
  <id_info>
    <org_study_id>1235.18</org_study_id>
    <nct_id>NCT02259803</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability of Telmisartan/Amlodipine Fixed-dose Combination Compared to Its Mono-components in Healthy Male Volunteers</brief_title>
  <official_title>Relative Bioavailability of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet Compared to Concomitant Use of Its Mono-components (i.e., Two Telmisartan 40 mg Tablets and Amlodipine 5 mg Tablet in Concomitant Use) Following Oral Administration 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>
      Study to investigate the relative bioavailability of fixed-dose combination tablet vs.&#xD;
&#xD;
      mono-components of telmisartan and amlodipine&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2007</start_date>
  <primary_completion_date type="Actual">November 2007</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 the last quantifiable data point (AUC0-tz)</measure>
    <time_frame>up to 144 hours after administration of study drug</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>up to 144 hours after administration of study drug</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 144 hours after administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from administration to the maximum concentration of the analyte in plasma (tmax)</measure>
    <time_frame>up to 144 hours after administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant of the analyte in plasma (λz)</measure>
    <time_frame>up to 144 hours after administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant of the analyte in plasma (t1/2)</measure>
    <time_frame>up to 144 hours after administration of study drug</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 144 hours after administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 56 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan/amlodipine fixed-dose combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan and amlodipine mono-components</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan/amlodipine fixed-dose combination (FDC) tablet</intervention_name>
    <arm_group_label>Telmisartan/amlodipine fixed-dose combination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Telmisartan and amlodipine mono-components</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine</intervention_name>
    <arm_group_label>Telmisartan and amlodipine mono-components</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, including the physical examination, vital signs&#xD;
             (blood pressure, pulse rate and body temperature), 12-lead ECG, clinical laboratory&#xD;
             tests, no finding of clinical relevance, no evidence of a clinically relevant&#xD;
             concomitant disease&#xD;
&#xD;
          2. Age ≥20 and Age ≤35 years&#xD;
&#xD;
          3. Body weight ≥50 kg&#xD;
&#xD;
          4. BMI ≥17.6 and BMI ≤26.4 kg/m2 (Body Mass Index)&#xD;
&#xD;
          5. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice&#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. Any clinical relevant findings of the laboratory test deviating from normal&#xD;
&#xD;
          5. Positive result for hepatitis B antigen, anti hepatitis C virus anti bodies,&#xD;
             syphilitic test or HIV test&#xD;
&#xD;
          6. Surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          7. 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;
          8. History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis)&#xD;
&#xD;
          9. History of serious renal dysfunction&#xD;
&#xD;
         10. History of bilateral renal artery stenosis or renal artery stenosis in a solitary&#xD;
             kidney&#xD;
&#xD;
         11. History of cerebrovascular disorder&#xD;
&#xD;
         12. History of hyperkalemia&#xD;
&#xD;
         13. Known hypersensitivity to any component of the formulation, or to any other&#xD;
             angiotensin II receptor blockers, angiotensin converting enzyme or dihydropyridine&#xD;
&#xD;
         14. 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 prior to administration or during the trial&#xD;
&#xD;
         15. Use of drugs which might reasonably influence the results of the trial based on the&#xD;
             knowledge at the time of protocol preparation within 7 days prior to administration or&#xD;
             during the trial&#xD;
&#xD;
         16. Participation in another trial with an investigational drug within 4 months or 6&#xD;
             half-lives of the investigational drug prior to administration&#xD;
&#xD;
         17. Smoker (≥20 cigarettes/day)&#xD;
&#xD;
         18. 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;
         19. Drug abuse&#xD;
&#xD;
         20. Blood donation (more than 100 mL within 4 weeks prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
         21. Excessive physical activities (within 1 week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
         22. Intake of alcohol within 2 days prior to administration&#xD;
&#xD;
         23. Inability to comply with dietary regimen of study centre&#xD;
&#xD;
         24. Intake of any drugs/supplements with ingredient of hypericum perforatum or citrus&#xD;
             fruits (e.g. grapefruits, Sevilla orange) within 5 days prior to administration&#xD;
&#xD;
         25. Inability to refrain from smoking on trial days&#xD;
&#xD;
         26. Any other volunteers whom, the principal investigator or sub investigator would not&#xD;
             allow to 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 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 6, 2014</last_update_submitted>
  <last_update_submitted_qc>October 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 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>Amlodipine</mesh_term>
    <mesh_term>Telmisartan</mesh_term>
    <mesh_term>Telmisartan amlodipine combination</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/NCT02259803
org study id: 1235.18
nct id: NCT02259803
lead sponsor: 
Study to investigate the relative bioavailability of fixed-dose combination tablet vs.

      mono-components of telmisartan and amlodipine
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 the last quantifiable data point (AUC0-tz)
time frame: up to 144 hours after administration of study drug
measure: Maximum measured concentration of the analyte in plasma (Cmax)
time frame: up to 144 hours after administration of study drug
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 144 hours after administration of study drug
measure: Time from administration to the maximum concentration of the analyte in plasma (tmax)
time frame: up to 144 hours after administration of study drug
measure: Terminal rate constant of the analyte in plasma (λz)
time frame: up to 144 hours after administration of study drug
measure: Terminal rate constant of the analyte in plasma (t1/2)
time frame: up to 144 hours after administration of study drug
measure: Mean residence time of the analyte in the body after po administration (MRTpo)
time frame: up to 144 hours after administration of study drug
measure: Number of subjects with adverse events
time frame: up to 56 days
arm group label: Telmisartan/amlodipine fixed-dose combination
arm group type: Experimental
arm group label: Telmisartan and amlodipine mono-components
arm group type: Active Comparator
intervention type: Drug
intervention name: Telmisartan/amlodipine fixed-dose combination (FDC) tablet
arm group label: Telmisartan/amlodipine fixed-dose combination
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan and amlodipine mono-components
intervention type: Drug
intervention name: Amlodipine
arm group label: Telmisartan and amlodipine mono-components
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: Amlodipine
mesh term: Telmisartan
mesh term: Telmisartan amlodipine combination