<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/NCT02262780</url>
  </required_header>
  <id_info>
    <org_study_id>502.453</org_study_id>
    <nct_id>NCT02262780</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of Single Rising and Multiple Oral Doses of Telmisartan / Hydrochlorothiazide (HCTZ) in Healthy Male Volunteers</brief_title>
  <official_title>Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (40 mg Telmisartan / 12.5 mg HCTZ to 80 mg Telmisartan / 12.5 mg HCTZ) and Multiple Oral Doses (80 mg Telmisartan / 12.5 mg HCTZ) of Drug in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Group 1:&#xD;
&#xD;
      To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and&#xD;
      T80/H12.5)&#xD;
&#xD;
      Group 2:&#xD;
&#xD;
      To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7&#xD;
      days)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2003</start_date>
  <primary_completion_date type="Actual">February 2004</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with clinically relevant findings in physical examination</measure>
    <time_frame>up to 10 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant findings in vital signs</measure>
    <time_frame>up to 10 days after last drug administration</time_frame>
    <description>blood pressure, pulse rate, body temperature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant findings in 12-lead ECG</measure>
    <time_frame>up to 10 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant findings in clinical laboratory tests</measure>
    <time_frame>up to 10 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 10 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Global assessment of tolerability by the investigator</measure>
    <time_frame>up to 10 days after last drug administration</time_frame>
    <description>verbal rating scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration of the analytes in plasma (Cmax)</measure>
    <time_frame>Up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration time curve of the analytes in plasma (AUC)</measure>
    <time_frame>Up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to maximum concentration of the analytes in plasma (tmax)</measure>
    <time_frame>Up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant of the analytes in plasma (λz)</measure>
    <time_frame>Up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of the analytes in plasma (t1/2)</measure>
    <time_frame>Up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of the analytes in the body after po administration (MRTpo)</measure>
    <time_frame>Up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of the analytes in the plasma after extravascular administration (CL/F)</measure>
    <time_frame>Up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution of the analytes in plasma during the terminal phase λz following an extravascular dose (Vz/F)</measure>
    <time_frame>Up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of HCTZ that is eliminated in urine from the time interval t1 to t2 (Aet1-t2)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of HCTZ excreted unchanged in urine from time point t1 to t2 (fet1-t2)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance of HCTZ in plasma from the time point t1 until the time point t2 (CLR, t1-t2)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)</measure>
    <time_frame>Up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average concentration of the analytes in plasma at steady state (Cavg)</measure>
    <time_frame>Up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio of the analytes in plasma after multiple dose administration over a uniform dosing interval τ (RA)</measure>
    <time_frame>Up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Single low dose Telmisartan with HCTZ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Single high dose Telmisartan with HCTZ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple high dose Telmisartan with HCTZ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose of telmisartan</intervention_name>
    <arm_group_label>Single low dose Telmisartan with HCTZ</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose of telmisartan</intervention_name>
    <arm_group_label>Multiple high dose Telmisartan with HCTZ</arm_group_label>
    <arm_group_label>Single high dose Telmisartan with HCTZ</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HCTZ</intervention_name>
    <arm_group_label>Multiple high dose Telmisartan with HCTZ</arm_group_label>
    <arm_group_label>Single high dose Telmisartan with HCTZ</arm_group_label>
    <arm_group_label>Single low dose Telmisartan with HCTZ</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males according to the following criteria: No finding deviating of clinical&#xD;
             relevance and no evidence of a clinically relevant concomitant disease based upon a&#xD;
             complete medical history, including the physical examination, vital signs (blood&#xD;
             pressure (BP), pulse rate (PR), body temperature), 12-lead ECG, clinical laboratory&#xD;
             tests&#xD;
&#xD;
          -  Age ≥20 and Age ≤35 years&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥17.6 and BMI ≤26.4 kg/m2&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with &quot;Good Clinical Practice (GCP)&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Positive result for hepatitis B surface (HBs) antigen, anti hepatitis C virus (HCV)&#xD;
             antibodies, Syphilitic test or HIV test&#xD;
&#xD;
          -  Surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  History of relevant orthostatic hypotension (mean standing SBP varies by ≥ 20 mmHg&#xD;
             from mean supine systolic blood pressure (SBP) and/or mean standing diastolic blood&#xD;
             pressure (DBP) varies by ≥ 10 mmHg from mean supine DBP), fainting spells or&#xD;
             blackouts.&#xD;
&#xD;
          -  History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis)&#xD;
&#xD;
          -  History of serious renal dysfunction&#xD;
&#xD;
          -  History of bilateral renal artery stenosis or renal artery stenosis in a solitary&#xD;
             kidney&#xD;
&#xD;
          -  History of cerebrovascular disorder&#xD;
&#xD;
          -  History of hyperkalemia&#xD;
&#xD;
          -  Known hypersensitivity to any component of the formulation; known hypersensitivity to&#xD;
             any other angiotensin II receptor antagonist; known hypersensitivity to sulfonamides&#xD;
             or sulphonamide-derived drugs (e.g. thiazides)&#xD;
&#xD;
          -  History of impaired glucose tolerance&#xD;
&#xD;
          -  History of hypokalemia&#xD;
&#xD;
          -  History of hyperuricemia&#xD;
&#xD;
          -  Salt restriction therapy&#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 based on the&#xD;
             knowledge at the time of protocol preparation within 7 days prior to administration or&#xD;
             during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within four months or 6&#xD;
             half-lives of the investigational drug, whichever is longer, prior to administration&#xD;
             or during the trial&#xD;
&#xD;
          -  Smoker (more than 20 cigarettes /day)&#xD;
&#xD;
          -  Alcohol abuse&#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 seven days prior to administration)&#xD;
&#xD;
          -  Intake of alcohol within two days prior to administration&#xD;
&#xD;
          -  Inability to comply with dietary regimen of study centre&#xD;
&#xD;
          -  Inability to comply with smoking cessation during hospitalization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 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 10, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 10, 2014</last_update_submitted>
  <last_update_submitted_qc>October 10, 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>
  </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/NCT02262780
org study id: 502.453
nct id: NCT02262780
lead sponsor: 
Group 1:

      To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and
      T80/H12.5)

      Group 2:

      To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7
      days)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with clinically relevant findings in physical examination
time frame: up to 10 days after last drug administration
measure: Number of patients with clinically relevant findings in vital signs
time frame: up to 10 days after last drug administration
description: blood pressure, pulse rate, body temperature
measure: Number of patients with clinically relevant findings in 12-lead ECG
time frame: up to 10 days after last drug administration
measure: Number of patients with clinically relevant findings in clinical laboratory tests
time frame: up to 10 days after last drug administration
measure: Number of patients with adverse events
time frame: up to 10 days after last drug administration
measure: Global assessment of tolerability by the investigator
time frame: up to 10 days after last drug administration
description: verbal rating scale
measure: Maximum concentration of the analytes in plasma (Cmax)
time frame: Up to 96 hours after drug administration
measure: Area under the concentration time curve of the analytes in plasma (AUC)
time frame: Up to 96 hours after drug administration
measure: Time from dosing to maximum concentration of the analytes in plasma (tmax)
time frame: Up to 96 hours after drug administration
measure: Terminal rate constant of the analytes in plasma (λz)
time frame: Up to 96 hours after drug administration
measure: Terminal half-life of the analytes in plasma (t1/2)
time frame: Up to 96 hours after drug administration
measure: Mean residence time of the analytes in the body after po administration (MRTpo)
time frame: Up to 96 hours after drug administration
measure: Apparent clearance of the analytes in the plasma after extravascular administration (CL/F)
time frame: Up to 96 hours after drug administration
measure: Apparent volume of distribution of the analytes in plasma during the terminal phase λz following an extravascular dose (Vz/F)
time frame: Up to 96 hours after drug administration
measure: Amount of HCTZ that is eliminated in urine from the time interval t1 to t2 (Aet1-t2)
time frame: Up to 48 hours after drug administration
measure: Fraction of HCTZ excreted unchanged in urine from time point t1 to t2 (fet1-t2)
time frame: Up to 48 hours after drug administration
measure: Renal clearance of HCTZ in plasma from the time point t1 until the time point t2 (CLR, t1-t2)
time frame: Up to 48 hours after drug administration
measure: Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
time frame: Up to 96 hours after drug administration
measure: Average concentration of the analytes in plasma at steady state (Cavg)
time frame: Up to 96 hours after drug administration
measure: Accumulation ratio of the analytes in plasma after multiple dose administration over a uniform dosing interval τ (RA)
time frame: Up to 96 hours after drug administration
arm group label: Single low dose Telmisartan with HCTZ
arm group type: Experimental
arm group label: Single high dose Telmisartan with HCTZ
arm group type: Experimental
arm group label: Multiple high dose Telmisartan with HCTZ
arm group type: Experimental
intervention type: Drug
intervention name: Low dose of telmisartan
arm group label: Single low dose Telmisartan with HCTZ
intervention type: Drug
intervention name: High dose of telmisartan
arm group label: Multiple high dose Telmisartan with HCTZ
arm group label: Single high dose Telmisartan with HCTZ
intervention type: Drug
intervention name: HCTZ
arm group label: Multiple high dose Telmisartan with HCTZ
arm group label: Single high dose Telmisartan with HCTZ
arm group label: Single low dose Telmisartan with HCTZ
criteria: 
gender: All
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Telmisartan