<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/NCT02214966</url>
  </required_header>
  <id_info>
    <org_study_id>1236.3</org_study_id>
    <nct_id>NCT02214966</nct_id>
  </id_info>
  <brief_title>Influence of Food on the Bioavailability of Telmisartan / Ramipril Fixed Dose Combination in Healthy Male and Female Volunteers</brief_title>
  <official_title>Influence of Food on the Bioavailability of 80 mg Telmisartan / 10 mg Ramipril Fixed Dose Combination in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-sequence, 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>
      The objective was to investigate the relative bioavailability of the fixed dose combination&#xD;
      (FDC) tablet (80 mg telmisartan / 10 mg ramipril) after food intake in comparison to the&#xD;
      bioavailability of the FDC tablet while fasting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2007</start_date>
  <primary_completion_date type="Actual">December 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-∞ (area under the concentration-time curve of the analytes 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>AUC0-24 (area under the concentration-time curve of the analytes in plasma over one dosing interval from 0 to 24h)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of the analytes in plasma)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of ramipril 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>
  </primary_outcome>
  <primary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of the analytes in plasma)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_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 three analytes 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 analytes 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 analytes 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 54 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>Day 5 of each treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in Vital Signs (Blood Pressure, Pulse Rate)</measure>
    <time_frame>up to 54 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in laboratory tests</measure>
    <time_frame>up to 54 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in Electrocardiogram (ECG)</measure>
    <time_frame>up to 54 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of ramiprilat and telmisartan 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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan/Ramipril, fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan/Ramipril, fasted</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan/Ramipril, fixed dose combination tablet</intervention_name>
    <arm_group_label>Telmisartan/Ramipril, fasted</arm_group_label>
    <arm_group_label>Telmisartan/Ramipril, fed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high fat, high caloric meal</intervention_name>
    <arm_group_label>Telmisartan/Ramipril, fed</arm_group_label>
  </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 ≤55 years&#xD;
&#xD;
          -  Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2&#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 or that prolong&#xD;
             the QT/QTc interval based on the knowledge at the time of protocol preparation within&#xD;
             10 days prior to administration or during the 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&#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 of trial drug&#xD;
             or during the 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 BP&#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;
          -  Salt and/or volume depletion&#xD;
&#xD;
        For female subjects:&#xD;
&#xD;
          -  Pregnancy / positive pregnancy test, or planning to become pregnant during the study&#xD;
             or within 1 month of study completion&#xD;
&#xD;
          -  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;
          -  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/NCT02214966
org study id: 1236.3
nct id: NCT02214966
lead sponsor: 
The objective was to investigate the relative bioavailability of the fixed dose combination
      (FDC) tablet (80 mg telmisartan / 10 mg ramipril) after food intake in comparison to the
      bioavailability of the FDC tablet while fasting.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-∞ (area under the concentration-time curve of the analytes in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 96 hours after drug administration
measure: AUC0-24 (area under the concentration-time curve of the analytes in plasma over one dosing interval from 0 to 24h)
time frame: up to 96 hours after drug administration
measure: Cmax (maximum measured concentration of the analytes in plasma)
time frame: up to 96 hours after drug administration
measure: AUC0-tz (area under the concentration-time curve of ramipril 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: tmax (time from dosing to the maximum concentration of the analytes 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 three analytes in plasma)
time frame: up to 96 hours after drug administration
measure: MRTpo (mean residence time of the analytes in the body after po administration)
time frame: up to 96 hours after drug administration
measure: CL/F (apparent clearance of the analytes 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 54 days
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: Day 5 of each treatment period
measure: Number of patients with clinically significant changes in Vital Signs (Blood Pressure, Pulse Rate)
time frame: up to 54 days
measure: Number of patients with clinically significant changes in laboratory tests
time frame: up to 54 days
measure: Number of patients with clinically significant changes in Electrocardiogram (ECG)
time frame: up to 54 days
measure: AUC0-tz (area under the concentration-time curve of ramiprilat and telmisartan 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
arm group label: Telmisartan/Ramipril, fed
arm group type: Experimental
arm group label: Telmisartan/Ramipril, fasted
arm group type: Active Comparator
intervention type: Drug
intervention name: Telmisartan/Ramipril, fixed dose combination tablet
arm group label: Telmisartan/Ramipril, fasted
arm group label: Telmisartan/Ramipril, fed
intervention type: Other
intervention name: high fat, high caloric meal
arm group label: Telmisartan/Ramipril, fed
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