<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/NCT02262572</url>
  </required_header>
  <id_info>
    <org_study_id>502.415</org_study_id>
    <nct_id>NCT02262572</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability of Telmisartan and HCTZ in Two Experimental Formulations Compared to the Standard Formulation Telmisartan and HCTZ in Healthy Female and Male Subjects</brief_title>
  <official_title>Relative Bioavailability of Telmisartan and HCTZ p.o. (80 mg Telmisartan/12.5 mg HCTZ) in Two Experimental Formulations (Given t.i.d. for One Day Each) Compared to the Standard Formulation 80 mg Telmisartan/12.5 mg HCTZ (MicardisPlus®), Given t.i.d. for One Day in Healthy Female and Male Subjects. A Three-way Crossover, Open, Randomised 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 assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations&#xD;
      based on sodium salt compared to the present commercial formulation (MicardisPlus®)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2003</start_date>
  <primary_completion_date type="Actual">August 2003</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 analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 72 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 72 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of HCTZ excreted in urine over 48 hours (%Ae0-48h)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>tmax (Time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 72 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 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLtot/F (Apparent clearance of the analyte in plasma following extravascular administration)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTtot (Total mean residence time)</measure>
    <time_frame>up to 72 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 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 32 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in vital signs</measure>
    <time_frame>up to 32 days</time_frame>
    <description>blood pressure, pulse rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in 12 lead ECG</measure>
    <time_frame>up to 32 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator's assessment of tolerability on a 4-point scale</measure>
    <time_frame>up to 32 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan /HCTZ - compression tablet (DC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan /HCTZ - dry granulation tablet (DG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan /HCTZ - present commercial formulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan /HCTZ - compression tablet (DC)</intervention_name>
    <arm_group_label>Telmisartan /HCTZ - compression tablet (DC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan /HCTZ - dry granulation tablet (DG)</intervention_name>
    <arm_group_label>Telmisartan /HCTZ - dry granulation tablet (DG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan /HCTZ - present commercial formulation</intervention_name>
    <arm_group_label>Telmisartan /HCTZ - present commercial formulation</arm_group_label>
    <other_name>MicardisPlus®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects meeting the following criteria will be eligible for participation in the study:&#xD;
&#xD;
          -  Healthy male and female subjects according to the following criteria: based upon a&#xD;
             complete medical history, including the physical examination, vital signs (BP, HR),&#xD;
             12-lead ECG, clinical laboratory tests.&#xD;
&#xD;
          -  Laboratory values within a clinically defined reference range&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice (GCP) and local legislation&#xD;
&#xD;
          -  Age &gt;=18 and Age &lt;=55 years&#xD;
&#xD;
          -  Body mass index (BMI) &gt;=18.5 and &lt;=29.9 kg/m2&#xD;
&#xD;
          -  Able to communicate well with the investigator and to comply with study requirements&#xD;
&#xD;
          -  Good condition of veins&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, heart rate, and&#xD;
             electrocardiogram) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Supine blood pressure at screening of systolic ≤ 110 mm Hg and diastolic ≤ 60 mmHg&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic&#xD;
             or hormonal disorders&#xD;
&#xD;
          -  Surgery of 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 an allergy/hypersensitivity (including drug allergy) which is deemed&#xD;
             relevant to the trial as judged by the investigator&#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 any drugs, which might reasonably influence the results of the trial based on&#xD;
             the knowledge at the time of protocol preparation within 10 days prior to&#xD;
             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 (more than 10 cigarettes or three cigars or three pipes/day)&#xD;
&#xD;
          -  Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation or loss of more than 400 mL within four weeks prior to administration&#xD;
             or during the trial&#xD;
&#xD;
          -  Excessive physical activities (within five days prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range of clinical relevance&#xD;
&#xD;
          -  History of hereditary fructose intolerance&#xD;
&#xD;
          -  Veins unsuited for i.v. puncture on either arm (e.g. veins which are difficult to&#xD;
             locate, access or puncture, veins with a tendency to rupture during or after puncture,&#xD;
             etc.)&#xD;
&#xD;
          -  Inability to comply with the dietary regimen of study centre&#xD;
&#xD;
          -  Inability to comply with the investigator's instructions.&#xD;
&#xD;
        For female subjects:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device&#xD;
             (IUD)&#xD;
&#xD;
          -  Inability to maintain this adequate contraception during the whole study period&#xD;
&#xD;
          -  Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 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 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 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 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>Hydrochlorothiazide</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/NCT02262572
org study id: 502.415
nct id: NCT02262572
lead sponsor: 
Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations
      based on sodium salt compared to the present commercial formulation (MicardisPlus®)
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 72 hours after drug administration
measure: Cmax (Maximum measured concentration of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: Amount of HCTZ excreted in urine over 48 hours (%Ae0-48h)
time frame: up to 48 hours after drug administration
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: t1/2 (Terminal half-life of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: CLtot/F (Apparent clearance of the analyte in plasma following extravascular administration)
time frame: up to 72 hours after drug administration
measure: MRTtot (Total mean residence time)
time frame: up to 72 hours after drug administration
measure: Vz/F (Apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: up to 72 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 32 days
measure: Number of subjects with clinically significant findings in vital signs
time frame: up to 32 days
description: blood pressure, pulse rate
measure: Number of subjects with clinically significant findings in 12 lead ECG
time frame: up to 32 days
measure: Investigator's assessment of tolerability on a 4-point scale
time frame: up to 32 days
arm group label: Telmisartan /HCTZ - compression tablet (DC)
arm group type: Experimental
arm group label: Telmisartan /HCTZ - dry granulation tablet (DG)
arm group type: Experimental
arm group label: Telmisartan /HCTZ - present commercial formulation
arm group type: Active Comparator
intervention type: Drug
intervention name: Telmisartan /HCTZ - compression tablet (DC)
arm group label: Telmisartan /HCTZ - compression tablet (DC)
intervention type: Drug
intervention name: Telmisartan /HCTZ - dry granulation tablet (DG)
arm group label: Telmisartan /HCTZ - dry granulation tablet (DG)
intervention type: Drug
intervention name: Telmisartan /HCTZ - present commercial formulation
arm group label: Telmisartan /HCTZ - present commercial formulation
other name: MicardisPlus®
criteria: 
gender: All
minimum age: 20 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: Hydrochlorothiazide