<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/NCT02214979</url>
  </required_header>
  <id_info>
    <org_study_id>1236.4</org_study_id>
    <nct_id>NCT02214979</nct_id>
  </id_info>
  <brief_title>Bioequivalence of Telmisartan / Ramipril Fixed Dose Combination Compared With the Monocomponents Given Concomitantly to Healthy Male and Female Volunteers</brief_title>
  <official_title>Bioequivalence of 40 mg Telmisartan / 2.5 mg Ramipril Fixed Dose Combination Compared With the Monocomponents, Telmisartan and Ramipril (Two Different Formulations) Given Concomitantly to Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Three-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 demonstrate the bioequivalence (BE) of 40 mg telmisartan/ 2.5 mg ramipril fixed-dose&#xD;
      combination (FDC) versus its monocomponents given concomitantly&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2007</start_date>
  <primary_completion_date type="Actual">June 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>AUC0-inf. (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (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)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of the analyte in the body after po administration)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of the analyte in the plasma after extravascular administration)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 73 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant changes in Vital Signs (Blood Pressure, Pulse Rate)</measure>
    <time_frame>up to 73 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant changes in laboratory tests</measure>
    <time_frame>up to 73 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant changes in 12-lead electrocardiogram</measure>
    <time_frame>up to 73 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan/Ramipril</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan + Ramipril capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartam + Ramipril tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan/Ramipril</intervention_name>
    <description>fixed dose combination tablet</description>
    <arm_group_label>Telmisartan/Ramipril</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Telmisartam + Ramipril tablet</arm_group_label>
    <arm_group_label>Telmisartan + Ramipril capsule</arm_group_label>
    <other_name>Micardis®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ramipril capsule</intervention_name>
    <arm_group_label>Telmisartan + Ramipril capsule</arm_group_label>
    <other_name>Altace®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ramipril tablet</intervention_name>
    <arm_group_label>Telmisartam + Ramipril tablet</arm_group_label>
    <other_name>Delix®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males and females according to the following criteria based upon a complete&#xD;
             medical history, including the physical examination, vital signs (Blood Pressure (BP),&#xD;
             Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests&#xD;
&#xD;
          -  Age ≥18 and Age ≤55 years&#xD;
&#xD;
          -  BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)&#xD;
&#xD;
          -  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;
          -  Any finding of the medical examination (including BP, PR and ECG) deviating from&#xD;
             normal and of clinical relevance&#xD;
&#xD;
          -  Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Surgery of the gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of relevant allergy/hypersensitivity (including allergy to drug or its&#xD;
             excipients)&#xD;
&#xD;
          -  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;
          -  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/QTc interval based on the knowledge at the&#xD;
             time of protocol preparation within 10 days prior to administration or during the&#xD;
             trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking during 24 hours prior to dosing and 24 hours after&#xD;
             dosing&#xD;
&#xD;
          -  Alcohol abuse (more than 60 g/day) or inability to stop alcoholic beverages for 24&#xD;
             hours prior to dosing and up to the last sampling time point, 96 hours after dosing.&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
          -  Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
          -  A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a&#xD;
             QTc interval &gt;450 ms)&#xD;
&#xD;
          -  A history of additional risk factors for torsade de pointes (e.g., heart failure,&#xD;
             hyperkalemia, hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
          -  Any history of relevant low blood pressure&#xD;
&#xD;
          -  Supine blood pressure at screening of systolic &lt;110 mm Hg and diastolic &lt;60 mm Hg&#xD;
&#xD;
          -  History of urticaria&#xD;
&#xD;
          -  History of angioneurotic edema&#xD;
&#xD;
          -  Hereditary fructose intolerance&#xD;
&#xD;
        For female subjects:&#xD;
&#xD;
          -  Pregnancy or planning to become pregnant during the study or within 2 months of study&#xD;
             completion&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  Are not willing or are unable to use a reliable method of contraception (such as&#xD;
             implants, injectables and combined oral contraceptives, sterilisation, intrauterine&#xD;
             device, double barrier method, sexual abstinence) for at least 1 month prior to&#xD;
             participation in the trial, during and up to 1 month after completion/termination of&#xD;
             the trial&#xD;
&#xD;
          -  Chronic use of oral contraception or hormone replacement containing ethinyl estradiol&#xD;
             as the only method of contraception&#xD;
&#xD;
          -  Currently lactating&#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>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 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>Telmisartan</mesh_term>
    <mesh_term>Ramipril</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/NCT02214979
org study id: 1236.4
nct id: NCT02214979
lead sponsor: 
Study to demonstrate the bioequivalence (BE) of 40 mg telmisartan/ 2.5 mg ramipril fixed-dose
      combination (FDC) versus its monocomponents given concomitantly
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-inf. (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 96 hours after drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 96 hours after drug administration
measure: AUC0-tz (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)
time frame: up to 96 hours after drug administration
measure: AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2)
time frame: up to 96 hours after drug administration
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 96 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: up to 96 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 96 hours after drug administration
measure: MRTpo (mean residence time of the analyte in the body after po administration)
time frame: up to 96 hours after drug administration
measure: CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
time frame: up to 96 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: up to 96 hours after drug administration
measure: Number of patients with adverse events
time frame: up to 73 days
measure: Number of patients with clinically relevant changes in Vital Signs (Blood Pressure, Pulse Rate)
time frame: up to 73 days
measure: Number of patients with clinically relevant changes in laboratory tests
time frame: up to 73 days
measure: Number of patients with clinically relevant changes in 12-lead electrocardiogram
time frame: up to 73 days
arm group label: Telmisartan/Ramipril
arm group type: Experimental
arm group label: Telmisartan + Ramipril capsule
arm group type: Active Comparator
arm group label: Telmisartam + Ramipril tablet
arm group type: Active Comparator
intervention type: Drug
intervention name: Telmisartan/Ramipril
description: fixed dose combination tablet
arm group label: Telmisartan/Ramipril
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartam + Ramipril tablet
arm group label: Telmisartan + Ramipril capsule
other name: Micardis®
intervention type: Drug
intervention name: Ramipril capsule
arm group label: Telmisartan + Ramipril capsule
other name: Altace®
intervention type: Drug
intervention name: Ramipril tablet
arm group label: Telmisartam + Ramipril tablet
other name: Delix®
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: Telmisartan
mesh term: Ramipril