<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/NCT02194309</url>
  </required_header>
  <id_info>
    <org_study_id>1235.9</org_study_id>
    <nct_id>NCT02194309</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine in Healthy Male Volunteers</brief_title>
  <official_title>Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine (Free Dose Combination) 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>
      To investigate safety, tolerability, and pharmacokinetics of telmisartan and amlodipine&#xD;
      following single administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5&#xD;
      mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan/5 mg&#xD;
      amlodipine and 80 mg telmisartan/5 mg amlodipine once daily for 10 days&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2006</start_date>
  <primary_completion_date type="Actual">December 2006</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate, body temperature)</measure>
    <time_frame>up to 6 days after last administration in multiple dose phase</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)</measure>
    <time_frame>up to 6 days after last administration in multiple dose phase</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant changes in laboratory parameters</measure>
    <time_frame>up to 6 days after last administration in multiple dose phase</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 6 days after last administration in multiple dose phase</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of tolerability by investigator on a four-point scale</measure>
    <time_frame>up to 6 days after last administration in multiple dose phase</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma) for several time points</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum measured concentration of the analyte in plasma) for several time points</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC (area under the concentration-time curve of the analyte in plasma) for several time points</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma) for several time points</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma) for several time points</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of the analyte in the body after oral administration) for several time points</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of the analyte in plasma following extravascular administration) for several time points</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration) for several time points</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio (RA) based on Cmax</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RA based on AUC</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predose concentration (Cpre) for several time points</measure>
    <time_frame>up to day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C24,10</measure>
    <time_frame>24 hours after last administration on day 10</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan low + amlodipine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan high + amlodipine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan low</intervention_name>
    <arm_group_label>Telmisartan low + amlodipine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan high</intervention_name>
    <arm_group_label>Telmisartan high + amlodipine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>amlodipine</intervention_name>
    <arm_group_label>Telmisartan high + amlodipine</arm_group_label>
    <arm_group_label>Telmisartan low + amlodipine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy male volunteers according to the following criteria:&#xD;
&#xD;
          1. No finding deviating of clinical relevance and no evidence of a clinically relevant&#xD;
             concomitant disease based upon a complete medical history, including the physical&#xD;
             examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead ECG,&#xD;
             clinical laboratory tests&#xD;
&#xD;
          2. Age ≥20 and Age ≤35 years&#xD;
&#xD;
          3. Body weight ≥50 kg&#xD;
&#xD;
          4. Body mass index (BMI) ≥17.6 and BMI ≤26.4 kg/m2&#xD;
&#xD;
          5. Signed and dated written informed consent before admission to the trial&#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 either hepatitis B surface antigen (HBsAg), anti hepatitis C virus&#xD;
             (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test&#xD;
&#xD;
          6. History of surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          7. History of relevant orthostatic hypotension (mean standing systolic blood pressure&#xD;
             (SBP) varied by ≥20 mmHg from mean supine SBP or mean standing diastolic blood&#xD;
             pressure (DBP) varied 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 Receptor Blocker (ARB), 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 before 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 before 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 before 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 before administration or during the&#xD;
             trial)&#xD;
&#xD;
         21. Excessive physical activities (within 1 week before administration or during the&#xD;
             trial)&#xD;
&#xD;
         22. Intake of alcohol within 2 days before administration&#xD;
&#xD;
         23. Inability to comply with dietary regimen of trial centre&#xD;
&#xD;
         24. Intake of any drugs/supplements with ingredient of hypericum perforatum (citrus&#xD;
             fruits, Sevilla orange) within 5 days prior to administration&#xD;
&#xD;
         25. Inability to refrain from smoking on trial days&#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>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 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/NCT02194309
org study id: 1235.9
nct id: NCT02194309
lead sponsor: 
To investigate safety, tolerability, and pharmacokinetics of telmisartan and amlodipine
      following single administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5
      mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan/5 mg
      amlodipine and 80 mg telmisartan/5 mg amlodipine once daily for 10 days
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate, body temperature)
time frame: up to 6 days after last administration in multiple dose phase
measure: Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
time frame: up to 6 days after last administration in multiple dose phase
measure: Number of patients with clinically significant changes in laboratory parameters
time frame: up to 6 days after last administration in multiple dose phase
measure: Number of patients with adverse events
time frame: up to 6 days after last administration in multiple dose phase
measure: Assessment of tolerability by investigator on a four-point scale
time frame: up to 6 days after last administration in multiple dose phase
measure: Cmax (maximum measured concentration of the analyte in plasma) for several time points
time frame: up to day 16
measure: tmax (time from dosing to the maximum measured concentration of the analyte in plasma) for several time points
time frame: up to day 16
measure: Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
time frame: up to day 16
measure: AUC (area under the concentration-time curve of the analyte in plasma) for several time points
time frame: up to day 16
measure: λz (terminal rate constant in plasma) for several time points
time frame: up to day 16
measure: t1/2 (terminal half-life of the analyte in plasma) for several time points
time frame: up to day 16
measure: MRTpo (mean residence time of the analyte in the body after oral administration) for several time points
time frame: up to day 16
measure: CL/F (apparent clearance of the analyte in plasma following extravascular administration) for several time points
time frame: up to day 16
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration) for several time points
time frame: up to day 16
measure: Accumulation ratio (RA) based on Cmax
time frame: up to day 16
measure: RA based on AUC
time frame: up to day 16
measure: Predose concentration (Cpre) for several time points
time frame: up to day 10
measure: C24,10
time frame: 24 hours after last administration on day 10
arm group label: Telmisartan low + amlodipine
arm group type: Experimental
arm group label: Telmisartan high + amlodipine
arm group type: Experimental
intervention type: Drug
intervention name: Telmisartan low
arm group label: Telmisartan low + amlodipine
intervention type: Drug
intervention name: Telmisartan high
arm group label: Telmisartan high + amlodipine
intervention type: Drug
intervention name: amlodipine
arm group label: Telmisartan high + amlodipine
arm group label: Telmisartan low + amlodipine
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