<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/NCT02187523</url>
  </required_header>
  <id_info>
    <org_study_id>502.324</org_study_id>
    <nct_id>NCT02187523</nct_id>
  </id_info>
  <brief_title>Relative Oral Bioavailability of Telmisartan / Hydrochlorothiazide (HCTZ) Fixed Dose Combination (FDC) Compared With Its Monocomponents in Healthy Subjects</brief_title>
  <official_title>Relative Oral Bioavailability of 40 mg Telmisartan / 12.5 mg HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Subjects. A 4 Period Cross-over, Open, Randomized, Replicate Design 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>
      A study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose&#xD;
      combination in comparison to the single unit formulations&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 1999</start_date>
  <primary_completion_date type="Actual">December 1999</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>Total area under concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)</measure>
    <time_frame>Pre-dose up to day 54</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum concentration of the analytes in plasma (Cmax)</measure>
    <time_frame>Pre-dose up to day 54</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of HCTZ excreted in urine over 48 h (Ae(0-48))</measure>
    <time_frame>Pre-dose up to day 50</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>time to achieve maximum concentration of the analytes in plasma (tmax)</measure>
    <time_frame>Pre-dose up to day 54</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination half life of the analytes in plasma (t1/2)</measure>
    <time_frame>Pre-dose up to day 54</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total clearance of the of the analytes after oral administration (CLtot/f)</measure>
    <time_frame>Pre-dose up to day 54</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total mean residence time of the analytes (MRTtot)</measure>
    <time_frame>Pre-dose up to day 54</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution of the analytes during the terminal phase (Vz/f)</measure>
    <time_frame>Pre-dose up to day 54</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with relevant changes in laboratory values</measure>
    <time_frame>Screening (day -14 to day 0) and day 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with relevant changes in vital signs (blood pressure, pulse rate)</measure>
    <time_frame>Up to day 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with Adverse events</measure>
    <time_frame>Up to day 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with relevant changes in ECG</measure>
    <time_frame>Screening (day -14 to day 0) and day 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with relevant changes in physical examination</measure>
    <time_frame>Screening (day -14 to day 0) and day 72</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Telmisartan/HCTZ FDC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan and HCTZ individual tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrochlorothiazide</intervention_name>
    <arm_group_label>Telmisartan and HCTZ individual tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Telmisartan and HCTZ individual tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan/HCTZ FDC</intervention_name>
    <arm_group_label>Telmisartan/HCTZ FDC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects as determined by results of screening&#xD;
&#xD;
          -  Signed written informed consent in accordance with good clinical practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 55 years&#xD;
&#xD;
          -  Broca ≥ -20 % and ≤ +20 %&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any findings of the medical examination (including blood pressure, pulse rate and&#xD;
             electrocardiogram (ECG)) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Surgery of the gastro-intestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting, spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infection&#xD;
&#xD;
          -  History or allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) ≤ 1 month prior to administration&#xD;
             or during the trial&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial (≤ 10 days prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (≤ 2 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 on study days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (≤ 1 month prior to administration or during the trial)&#xD;
&#xD;
          -  Excessive physical activities (≤ 5 days prior to administration or during the trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range of clinical relevance&#xD;
&#xD;
          -  Hypersensitivity to Telmisartan and/or HCTZ and/or related classes of drugs&#xD;
&#xD;
        For female subjects:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  No adequate contraception (e.g. sterilization, intrauterine device (IUD), oral&#xD;
             contraceptives)&#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>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/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.324_U00-1275.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 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>Hydrochlorothiazide</mesh_term>
    <mesh_term>Telmisartan</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/NCT02187523
org study id: 502.324
nct id: NCT02187523
lead sponsor: 
A study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose
      combination in comparison to the single unit formulations
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total area under concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)
time frame: Pre-dose up to day 54
measure: Maximum concentration of the analytes in plasma (Cmax)
time frame: Pre-dose up to day 54
measure: Amount of HCTZ excreted in urine over 48 h (Ae(0-48))
time frame: Pre-dose up to day 50
measure: time to achieve maximum concentration of the analytes in plasma (tmax)
time frame: Pre-dose up to day 54
measure: Terminal elimination half life of the analytes in plasma (t1/2)
time frame: Pre-dose up to day 54
measure: Total clearance of the of the analytes after oral administration (CLtot/f)
time frame: Pre-dose up to day 54
measure: Total mean residence time of the analytes (MRTtot)
time frame: Pre-dose up to day 54
measure: Apparent volume of distribution of the analytes during the terminal phase (Vz/f)
time frame: Pre-dose up to day 54
measure: Number of patients with relevant changes in laboratory values
time frame: Screening (day -14 to day 0) and day 72
measure: Number of patients with relevant changes in vital signs (blood pressure, pulse rate)
time frame: Up to day 72
measure: Number of patients with Adverse events
time frame: Up to day 72
measure: Number of patients with relevant changes in ECG
time frame: Screening (day -14 to day 0) and day 72
measure: Number of patients with relevant changes in physical examination
time frame: Screening (day -14 to day 0) and day 72
arm group label: Telmisartan/HCTZ FDC
arm group type: Experimental
arm group label: Telmisartan and HCTZ individual tablets
arm group type: Active Comparator
intervention type: Drug
intervention name: Hydrochlorothiazide
arm group label: Telmisartan and HCTZ individual tablets
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan and HCTZ individual tablets
intervention type: Drug
intervention name: Telmisartan/HCTZ FDC
arm group label: Telmisartan/HCTZ FDC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.324_U00-1275.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Hydrochlorothiazide
mesh term: Telmisartan