<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/NCT02259829</url>
  </required_header>
  <id_info>
    <org_study_id>1235.3</org_study_id>
    <nct_id>NCT02259829</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Telmisartan/Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers</brief_title>
  <official_title>Bioequivalence of 40 mg Telmisartan/5 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, Two-period 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 demonstrate the bioequivalence of 40 mg telmisartan / 5 mg amlodipine fixed dose&#xD;
      combination vs. its monocomponents&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 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 extrapolated to infinity (AUC0-∞)</measure>
    <time_frame>up to 168 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 168 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 to the time of the last quantifiable data point (AUC0-tz)</measure>
    <time_frame>up to 168 hours after administration of study drug</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 168 hours after administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant in plasma (λz)</measure>
    <time_frame>up to 168 hours after administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of the analyte in plasma (t1/2)</measure>
    <time_frame>up to 168 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 168 hours after administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of the analyte in plasma after p.o. administration (CL/F)</measure>
    <time_frame>up to 168 hours after administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apparent volume of distribution during the terminal phase λz after p.o. administration (Vz/F)</measure>
    <time_frame>up to 168 hours after administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 65 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>day 8 after administration of study drug</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</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 monocomponents</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan/Amlodipine</intervention_name>
    <description>Fixed dose combination tablet</description>
    <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 monocomponents</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 monocomponents</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 ≤55 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;
             except for oral contraceptives as well as ovary and thyroid hormone replacement&#xD;
&#xD;
         10. Use of drugs which might reasonably influence the results of the trial (especially&#xD;
             unspecific inducing agents like St.John´s wort (Hypericum perforatum) or inhibitors&#xD;
             like cimetidine) or that prolong the QT/corrected QT interval based on the knowledge&#xD;
             at the time of protocol preparation within 10 days prior to administration or during&#xD;
             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 during 24 hours prior to dosing and during the trial&#xD;
&#xD;
         14. Alcohol abuse or inability to stop alcoholic beverages for 24 hours prior to dosing&#xD;
             and during the trial&#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. Any history of relevant low blood pressure&#xD;
&#xD;
         20. Supine blood pressure at screening of systolic &lt;110 mm Hg and diastolic &lt;60 mm Hg&#xD;
&#xD;
         21. History of urticaria&#xD;
&#xD;
         22. History of angioneurotic edema&#xD;
&#xD;
         23. Fructose intolerance&#xD;
&#xD;
             For female subjects:&#xD;
&#xD;
         24. Pregnancy / positive pregnancy test, or planning to become pregnant during the study&#xD;
             or within 1 month of study completion&#xD;
&#xD;
         25. No adequate contraception during the study and until 1 month of study completion, i.e.&#xD;
             implants, injectables, combined oral contraceptives, intrauterine device, sexual&#xD;
             abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy&#xD;
             performed at least 1 year prior to enrolment), or surgical sterilisation (incl.&#xD;
             hysterectomy). Females, who have not a vasectomised partner, are not sexually&#xD;
             abstinent or surgically sterile will be asked to additionally use barrier&#xD;
             contraception methods (e.g. condom, diaphragm with spermicide)&#xD;
&#xD;
         26. Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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/NCT02259829
org study id: 1235.3
nct id: NCT02259829
lead sponsor: 
Study to demonstrate the bioequivalence of 40 mg telmisartan / 5 mg amlodipine fixed dose
      combination vs. its monocomponents
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 extrapolated to infinity (AUC0-∞)
time frame: up to 168 hours after administration of study drug
measure: Maximum measured concentration of the analyte in plasma (Cmax)
time frame: up to 168 hours after administration of study drug
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 168 hours after administration of study drug
measure: Time from dosing to the maximum concentration of the analyte in plasma (tmax)
time frame: up to 168 hours after administration of study drug
measure: Terminal rate constant in plasma (λz)
time frame: up to 168 hours after administration of study drug
measure: Terminal half-life of the analyte in plasma (t1/2)
time frame: up to 168 hours after administration of study drug
measure: mean residence time of the analyte in the body after po administration (MRTpo)
time frame: up to 168 hours after administration of study drug
measure: Apparent clearance of the analyte in plasma after p.o. administration (CL/F)
time frame: up to 168 hours after administration of study drug
measure: apparent volume of distribution during the terminal phase λz after p.o. administration (Vz/F)
time frame: up to 168 hours after administration of study drug
measure: Number of subjects with adverse events
time frame: up to 65 days
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: day 8 after administration of study drug
arm group label: Telmisartan/Amlodipine fixed dose combination
arm group type: Experimental
arm group label: Telmisartan and Amlodipine monocomponents
arm group type: Active Comparator
intervention type: Drug
intervention name: Telmisartan/Amlodipine
description: Fixed dose combination tablet
arm group label: Telmisartan/Amlodipine fixed dose combination
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan and Amlodipine monocomponents
other name: Micardis®
intervention type: Drug
intervention name: Amlodipine
arm group label: Telmisartan and Amlodipine monocomponents
other name: Norvasc®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 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