<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/NCT02259816</url>
  </required_header>
  <id_info>
    <org_study_id>1235.2</org_study_id>
    <nct_id>NCT02259816</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Telmisartan Alone and in Combination With Amlodipine in Healthy Volunteers</brief_title>
  <official_title>Pharmacokinetics of Repeated Oral Doses of 80 mg Telmisartan (Micardis®) at Steady State Alone and in Combination With Repeated Oral Doses of Amlodipine 10 mg (Norvasc®) at Steady State. A Two-way Crossover, Open, Randomised Design 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 steady state pharmacokinetics of 80 mg telmisartan alone and in&#xD;
      combination with repeated doses of 10 mg amlodipine&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2006</start_date>
  <primary_completion_date type="Actual">August 2006</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 telmisartan in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)</measure>
    <time_frame>up to 15 days after first administration of study drug</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of telmisartan in plasma at steady state over a uniform dosing interval τ (Cmax,ss)</measure>
    <time_frame>up to 15 days after first administration of study drug</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCτ,ss for amlodipine</measure>
    <time_frame>up to 15 days after first administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss for amlodipine</measure>
    <time_frame>up to 15 days after first administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum measured concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>up to 12 hours after first administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to maximum measured concentration on plasma (tmax)</measure>
    <time_frame>up to 12 hours after first administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve over a uniform dosing interval τ after administration of the first dose; corresponds to AUC0-24h (AUCτ,1)</measure>
    <time_frame>up to 12 hours after first administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-dose concentration of the analyte in plasma immediately before the administration of the next dose N (Cpre,N)</measure>
    <time_frame>pre-dose on days 2-9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)</measure>
    <time_frame>up to 144 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)</measure>
    <time_frame>up to 144 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant in plasma at steady state (λz,ss)</measure>
    <time_frame>up to 144 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of the analyte in plasma at steady state (t1/2, ss)</measure>
    <time_frame>up to 144 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)</measure>
    <time_frame>up to 144 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)</measure>
    <time_frame>up to 144 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution of the analyte in plasma at steady state after extravascular multiple dose administration (Vz/F,ss)</measure>
    <time_frame>up to 144 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio of the analyte in plasma based on AUC over a uniform dosing interval after the first and last doses (RA, AUC)</measure>
    <time_frame>up to 15 days after first administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio of the analyte in plasma based on Cmax over a uniform dosing interval after the last and first doses (RA,Cmax)</measure>
    <time_frame>up to 15 days after first administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 80 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>within 14 days after last trial procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan and amlodipine</arm_group_label>
    <arm_group_type>Experimental</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 amlodipine</arm_group_label>
    <other_name>Micardis®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine</intervention_name>
    <arm_group_label>Telmisartan and amlodipine</arm_group_label>
    <other_name>Norvasc®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males and females according to the following criteria:&#xD;
&#xD;
             Based upon a complete medical history, including the physical examination, vital signs&#xD;
             (BP, PR), 12-lead ECG, clinical laboratory tests&#xD;
&#xD;
          2. Age ≥18 and Age ≤50 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 and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any finding of the medical examination (including BP, PR and ECG) deviating from&#xD;
             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. Surgery of the gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          6. History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          7. Chronic or relevant acute infections&#xD;
&#xD;
          8. History of relevant allergy/hypersensitivity (including allergy to drug or its&#xD;
             excipients)&#xD;
&#xD;
          9. 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;
         10. Use of drugs which might reasonably influence the results of the trial or that prolong&#xD;
             the QT/corrected QT interval based on the knowledge at the time of protocol&#xD;
             preparation within 10 days prior to administration or during the trial&#xD;
&#xD;
         11. Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
         12. Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
         13. Inability to refrain from smoking on trial days&#xD;
&#xD;
         14. Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
         15. Drug abuse&#xD;
&#xD;
         16. Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
         17. Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
         18. Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
         19. Inability to comply with dietary regimen of trial site&#xD;
&#xD;
         20. Any history of relevant low blood pressure&#xD;
&#xD;
         21. Supine blood pressure at screening of systolic &lt;110 mm Hg and/or diastolic &lt;60 mm Hg&#xD;
&#xD;
         22. History of urticaria&#xD;
&#xD;
             For female subjects:&#xD;
&#xD;
         23. Pregnancy or planning to become pregnant within 2 months of study completion&#xD;
&#xD;
         24. Positive pregnancy test&#xD;
&#xD;
         25. No adequate contraception e.g. sterilisation, intrauterine device, have not been using&#xD;
             a barrier method of contraception for at least 3 months prior to participation in the&#xD;
             study&#xD;
&#xD;
         26. Are not willing or are unable to use a reliable method of barrier contraception (such&#xD;
             as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during&#xD;
             and up to 2 months after completion/termination of the trial&#xD;
&#xD;
         27. Chronic use of oral contraception or hormone replacement containing ethinyl estradiol&#xD;
             as the only method of contraception&#xD;
&#xD;
         28. Partner is unwilling to use condoms&#xD;
&#xD;
         29. Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 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>
  </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/NCT02259816
org study id: 1235.2
nct id: NCT02259816
lead sponsor: 
Study to investigate the steady state pharmacokinetics of 80 mg telmisartan alone and in
      combination with repeated doses of 10 mg amlodipine
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve of telmisartan in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
time frame: up to 15 days after first administration of study drug
measure: Maximum measured concentration of telmisartan in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
time frame: up to 15 days after first administration of study drug
measure: AUCτ,ss for amlodipine
time frame: up to 15 days after first administration of study drug
measure: Cmax,ss for amlodipine
time frame: up to 15 days after first administration of study drug
measure: Maximum measured concentration of the analyte in plasma (Cmax)
time frame: up to 12 hours after first administration of study drug
measure: Time from dosing to maximum measured concentration on plasma (tmax)
time frame: up to 12 hours after first administration of study drug
measure: Area under the plasma concentration-time curve over a uniform dosing interval τ after administration of the first dose; corresponds to AUC0-24h (AUCτ,1)
time frame: up to 12 hours after first administration of study drug
measure: Pre-dose concentration of the analyte in plasma immediately before the administration of the next dose N (Cpre,N)
time frame: pre-dose on days 2-9
measure: Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
time frame: up to 144 hours after last administration of study drug
measure: Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
time frame: up to 144 hours after last administration of study drug
measure: Terminal rate constant in plasma at steady state (λz,ss)
time frame: up to 144 hours after last administration of study drug
measure: Terminal half-life of the analyte in plasma at steady state (t1/2, ss)
time frame: up to 144 hours after last administration of study drug
measure: Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)
time frame: up to 144 hours after last administration of study drug
measure: Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)
time frame: up to 144 hours after last administration of study drug
measure: Apparent volume of distribution of the analyte in plasma at steady state after extravascular multiple dose administration (Vz/F,ss)
time frame: up to 144 hours after last administration of study drug
measure: Accumulation ratio of the analyte in plasma based on AUC over a uniform dosing interval after the first and last doses (RA, AUC)
time frame: up to 15 days after first administration of study drug
measure: Accumulation ratio of the analyte in plasma based on Cmax over a uniform dosing interval after the last and first doses (RA,Cmax)
time frame: up to 15 days after first administration of study drug
measure: Number of subjects with adverse events
time frame: up to 80 days
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: within 14 days after last trial procedure
arm group label: Telmisartan
arm group type: Active Comparator
arm group label: Telmisartan and amlodipine
arm group type: Experimental
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan
arm group label: Telmisartan and amlodipine
other name: Micardis®
intervention type: Drug
intervention name: Amlodipine
arm group label: Telmisartan and amlodipine
other name: Norvasc®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 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