<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/NCT02261064</url>
  </required_header>
  <id_info>
    <org_study_id>1235.27</org_study_id>
    <nct_id>NCT02261064</nct_id>
  </id_info>
  <brief_title>Influence of Food on the Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Japanese Male Volunteers</brief_title>
  <official_title>Influence of Food on the Bioavailability of Telmisartan 40 mg/Amlodipine 5 mg Fixed-dose Combination and of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination in Healthy Japanese Male Volunteers (a Phase I, Open-label, Randomised, Single-dose, Two-way Crossover Trial)</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 and pharmacokinetics of the fixed-dose&#xD;
      combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg)&#xD;
      in the fed condition compared with those of the same fixed-dose combination in the fasting&#xD;
      condition in healthy Japanese male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2008</start_date>
  <primary_completion_date type="Actual">February 2009</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 time of the last quantifiable data point (AUC0-tz)</measure>
    <time_frame>up to 144 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 144 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 144 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to the maximum concentration of the analyte in plasma (tmax)</measure>
    <time_frame>up to 144 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 144 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 144 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 144 hours after drug administration</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>4</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan/Amlodipine low dose, fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telmisartan low dose/Amlodipine fixed-dose combination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan/Amlodipine low dose, fasted</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telmisartan low dose/Amlodipine fixed-dose combination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan/Amlodipine high dose, fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telmisartan high dose/Amlodipine fixed-dose combination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan/Amlodipine high dose, fasted</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telmisartan high dose/Amlodipine fixed-dose combination</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan/Amlodipine low dose</intervention_name>
    <arm_group_label>Telmisartan/Amlodipine low dose, fasted</arm_group_label>
    <arm_group_label>Telmisartan/Amlodipine low dose, fed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan/Amlodipine high dose</intervention_name>
    <arm_group_label>Telmisartan/Amlodipine high dose, fasted</arm_group_label>
    <arm_group_label>Telmisartan/Amlodipine high dose, fed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Japanese meal</intervention_name>
    <arm_group_label>Telmisartan/Amlodipine high dose, fed</arm_group_label>
    <arm_group_label>Telmisartan/Amlodipine low dose, fed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male volunteers without any clinically significant findings and complications&#xD;
             on the basis of a complete medical history, including the physical examination, vital&#xD;
             signs (blood pressure, pulse rate, body temperature), 12-lead electrocardiograms&#xD;
             (ECGs), 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): ≥18.0 and ≤25.0 kg/m2&#xD;
&#xD;
          5. Signed and dated written informed consent prior to admission to the trial in&#xD;
             accordance with the Good Clinical Practice (GCP) 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. Diseases of the central nervous system (such as epilepsy) or psychiatric or&#xD;
             neurological disorders&#xD;
&#xD;
          3. Chronic or relevant acute infections&#xD;
&#xD;
          4. Any clinical relevant findings in laboratory test results deviating from normal&#xD;
&#xD;
          5. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV)&#xD;
             antibodies, a syphilitic test, or an human immunodeficiency virus (HIV) test&#xD;
&#xD;
          6. History of surgery of the gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          7. History of relevant orthostatic hypotension, fainting spells, or blackouts&#xD;
&#xD;
          8. Known hypersensitivity to any component of the formulation (telmisartan and&#xD;
             amlodipine), to any other angiotensin II receptor blockers, or to any other&#xD;
             dihydropyridine compound&#xD;
&#xD;
          9. Intake of drugs with a long half-life (≥24 hours) within at least 1 month or less than&#xD;
             10 half-lives of the respective drug before drug administration&#xD;
&#xD;
         10. Intake of drugs which might reasonably influence the results of the trial on the basis&#xD;
             of the knowledge at the time of protocol preparation within 7 days before drug&#xD;
             administration&#xD;
&#xD;
         11. Participation in another trial with an investigational drug within 4 months or 6&#xD;
             half-lives of the investigational products before drug administration&#xD;
&#xD;
         12. Smoker (≥20 cigarettes/day)&#xD;
&#xD;
         13. Alcohol abuse (60 g or more ethanol/day: e.g., 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 4 weeks before drug administration)&#xD;
&#xD;
         16. Excessive physical activities (within 1 week before drug administration)&#xD;
&#xD;
         17. Intake of alcohol within 2 days before drug administration&#xD;
&#xD;
         18. Inability to comply with dietary regimen of the study centre&#xD;
&#xD;
         19. Inability to refrain from smoking during trial days&#xD;
&#xD;
         20. Subjects judged to be inappropriate by the investigator or a sub-investigator&#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>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/NCT02261064
org study id: 1235.27
nct id: NCT02261064
lead sponsor: 
Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose
      combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg)
      in the fed condition compared with those of the same fixed-dose combination in the fasting
      condition in healthy Japanese male volunteers.
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 time of the last quantifiable data point (AUC0-tz)
time frame: up to 144 hours after drug administration
measure: Maximum measured concentration of the analyte in plasma (Cmax)
time frame: up to 144 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 144 hours after drug administration
measure: Time from dosing to the maximum concentration of the analyte in plasma (tmax)
time frame: up to 144 hours after drug administration
measure: Terminal rate constant of the analyte in plasma (λz)
time frame: up to 144 hours after drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
time frame: up to 144 hours after drug administration
measure: Mean residence time of the analyte in the body after po administration (MRTpo)
time frame: up to 144 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 56 days
arm group label: Telmisartan/Amlodipine low dose, fed
arm group type: Experimental
description: Telmisartan low dose/Amlodipine fixed-dose combination
arm group label: Telmisartan/Amlodipine low dose, fasted
arm group type: Active Comparator
description: Telmisartan low dose/Amlodipine fixed-dose combination
arm group label: Telmisartan/Amlodipine high dose, fed
arm group type: Experimental
description: Telmisartan high dose/Amlodipine fixed-dose combination
arm group label: Telmisartan/Amlodipine high dose, fasted
arm group type: Active Comparator
description: Telmisartan high dose/Amlodipine fixed-dose combination
intervention type: Drug
intervention name: Telmisartan/Amlodipine low dose
arm group label: Telmisartan/Amlodipine low dose, fasted
arm group label: Telmisartan/Amlodipine low dose, fed
intervention type: Drug
intervention name: Telmisartan/Amlodipine high dose
arm group label: Telmisartan/Amlodipine high dose, fasted
arm group label: Telmisartan/Amlodipine high dose, fed
intervention type: Other
intervention name: Japanese meal
arm group label: Telmisartan/Amlodipine high dose, fed
arm group label: Telmisartan/Amlodipine low dose, fed
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