<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/NCT02183675</url>
  </required_header>
  <id_info>
    <org_study_id>1348.5</org_study_id>
    <nct_id>NCT02183675</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Different Formulations of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) in Japanese Healthy Male Volunteers</brief_title>
  <official_title>Pharmacokinetics of Multiple Oral Doses of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet, Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet at Steady State in Healthy Male Subjects: an Open-label, Randomised, Multiple-dose, Three Treatment, Three-period, Six-sequence 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>
      To assess drug drug interaction through pharmacokinetics investigation at steady state of&#xD;
      Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations&#xD;
      in healthy Japanese male subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Maximum Measured Concentration (Cmax) at Steady State for Telmisartan</measure>
    <time_frame>15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration</time_frame>
    <description>Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration Curve at Steady State for Telmisartan</measure>
    <time_frame>15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration</time_frame>
    <description>Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Measured Concentration (Cmax) at Steady State for Amlodipine</measure>
    <time_frame>15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration</time_frame>
    <description>Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration Curve at Steady State for Amlodipine</measure>
    <time_frame>15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration</time_frame>
    <description>Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Measured Concentration (Cmax) at Steady State for HCTZ</measure>
    <time_frame>15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration</time_frame>
    <description>Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration Curve at Steady State for HCTZ</measure>
    <time_frame>15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration</time_frame>
    <description>Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours</measure>
    <time_frame>0-6 hours (h), 6-12h and 12-24h after drug administration on day 10</time_frame>
    <description>Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>T/A/H</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telmisartan/Amlodipine/HCTZ fixed-dose combination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T/A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telmisartan/Amlodipine fixed-dose combination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T/H</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telmisartan/HCTZ fixed-dose combination</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan/Amlodipine</intervention_name>
    <description>Telmisartan/Amlodipine fixed-dose combination</description>
    <arm_group_label>T/A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan/Amlodipine/HCTZ</intervention_name>
    <description>Telmisartan/Amlodipine/HCTZ fixed-dose combination</description>
    <arm_group_label>T/A/H</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan/HCTZ</intervention_name>
    <description>Telmisartan/HCTZ fixed-dose combination</description>
    <arm_group_label>T/H</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Healthy Japanese male subjects age &gt;=20 and &lt;=35 years; body weight: &gt;=50 kg and &lt;=80&#xD;
             kg; body mass index: &gt;=18.0 and &lt;=25.0 kg/m2&#xD;
&#xD;
          -  Without any clinically significant findings and complications on the basis of a&#xD;
             complete medical history, including the physical examination, vital signs (blood&#xD;
             pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiograms (ECGs),&#xD;
             clinical laboratory tests&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the trial in&#xD;
             accordance with the Good Clinical Practice (GCP) and the local legislation.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - Any finding of the medical examination (including BP, PR and ECGs) deviating from normal&#xD;
        and of clinical relevance.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1348.5.001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Kanagawa , Yokohama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <results_first_submitted>October 6, 2016</results_first_submitted>
  <results_first_submitted_qc>October 6, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 30, 2016</results_first_posted>
  <last_update_submitted>October 6, 2016</last_update_submitted>
  <last_update_submitted_qc>October 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</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>Amlodipine</mesh_term>
    <mesh_term>Telmisartan</mesh_term>
    <mesh_term>Hydrochlorothiazide</mesh_term>
    <mesh_term>Telmisartan amlodipine combination</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>An open-label, randomised, six-sequence crossover design. Each participant received three treatments each for 10 days. There was no washout period between treatments.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>T80-A5-H12.5 / T80-H12.5 / T80-A5</title>
          <description>Participants received the three treatments, the treatments were administered orally in the following order:&#xD;
Telmisartan 80mg/Amlodipine 5mg/ hydrochlorothiazide (HCTZ) 12.5mg fixed-dose combination tablet (T80-A5-H12.5)&#xD;
Telmisartan 80mg/ HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)&#xD;
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)</description>
        </group>
        <group group_id="P2">
          <title>T80-H12.5 / T80-A5 / T80-A5-H12.5</title>
          <description>Participants received the three treatments, the treatments were administered orally in the following order:&#xD;
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)&#xD;
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)&#xD;
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)</description>
        </group>
        <group group_id="P3">
          <title>T80-A5 / T80-A5-H12.5 / T80-H12.5</title>
          <description>Participants received the three treatments, the treatments were administered orally in the following order:&#xD;
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)&#xD;
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)&#xD;
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)</description>
        </group>
        <group group_id="P4">
          <title>T80-A5 / T80-H12.5 / T80-A5-H12.5</title>
          <description>Participants received the three treatments, the treatments were administered orally in the following order:&#xD;
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)&#xD;
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)&#xD;
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)</description>
        </group>
        <group group_id="P5">
          <title>T80-A5-H12.5 / T80-A5 / T80-H12.5</title>
          <description>Participants received the three treatments, the treatments were administered orally in the following order:&#xD;
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)&#xD;
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)&#xD;
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)</description>
        </group>
        <group group_id="P6">
          <title>T80-H12.5 / T80-A5-H12.5 / T80-A5</title>
          <description>Participants received the three treatments, the treatments were administered orally in the following order:&#xD;
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)&#xD;
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)&#xD;
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1 (10 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Period 2 (10 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="4">Patients withdrew after completion of treatment period 2 but before beginning of treatment period 3</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period 3 (10 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated set which included all subjects that were dispensed study drug and were documented to have taken at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>T80-A5-H12.5 / T80-H12.5 / T80-A5</title>
          <description>Participants received the three treatments, the treatments were administered orally in the following order:&#xD;
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)&#xD;
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)&#xD;
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)</description>
        </group>
        <group group_id="B2">
          <title>T80-H12.5 / T80-A5 / T80-A5-H12.5</title>
          <description>Participants received the three treatments, the treatments were administered orally in the following order:&#xD;
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)&#xD;
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)&#xD;
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)</description>
        </group>
        <group group_id="B3">
          <title>T80-A5 / T80-A5-H12.5 / T80-H12.5</title>
          <description>Participants received the three treatments, the treatments were administered orally in the following order:&#xD;
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)&#xD;
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)&#xD;
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)</description>
        </group>
        <group group_id="B4">
          <title>T80-A5 / T80-H12.5 / T80-A5-H12.5</title>
          <description>Participants received the three treatments, the treatments were administered orally in the following order:&#xD;
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)&#xD;
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)&#xD;
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)</description>
        </group>
        <group group_id="B5">
          <title>T80-A5-H12.5 / T80-A5 / T80-H12.5</title>
          <description>Participants received the three treatments, the treatments were administered orally in the following order:&#xD;
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)&#xD;
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)&#xD;
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)</description>
        </group>
        <group group_id="B6">
          <title>T80-H12.5 / T80-A5-H12.5 / T80-A5</title>
          <description>Participants received the three treatments, the treatments were administered orally in the following order:&#xD;
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)&#xD;
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)&#xD;
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.0" spread="4.9"/>
                    <measurement group_id="B2" value="27.3" spread="5.2"/>
                    <measurement group_id="B3" value="27.0" spread="4.2"/>
                    <measurement group_id="B4" value="25.8" spread="4.1"/>
                    <measurement group_id="B5" value="29.5" spread="5.1"/>
                    <measurement group_id="B6" value="29.3" spread="4.9"/>
                    <measurement group_id="B7" value="28.0" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Measured Concentration (Cmax) at Steady State for Telmisartan</title>
        <description>Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau</description>
        <time_frame>15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration</time_frame>
        <population>Pharmacokinetic (PK) set which included all subjects in the treated set who had evaluable PK variable of test (T80/A5/H12.5 mg) and at least one of two references (T80/H12.5 mg and T80/A5 mg) for treatment periods 1, 2, and 3. Subjects who had a protocol deviation relevant to the evaluation of relative bioavailability were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>T80-A5-H12.5</title>
            <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.</description>
          </group>
          <group group_id="O2">
            <title>T80-A5</title>
            <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days</description>
          </group>
          <group group_id="O3">
            <title>T80-H12.5</title>
            <description>Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Measured Concentration (Cmax) at Steady State for Telmisartan</title>
          <description>Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau</description>
          <population>Pharmacokinetic (PK) set which included all subjects in the treated set who had evaluable PK variable of test (T80/A5/H12.5 mg) and at least one of two references (T80/H12.5 mg and T80/A5 mg) for treatment periods 1, 2, and 3. Subjects who had a protocol deviation relevant to the evaluation of relative bioavailability were excluded.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="970" spread="69.3"/>
                    <measurement group_id="O2" value="857" spread="70.7"/>
                    <measurement group_id="O3" value="895" spread="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority limits: 80% - 125%</non_inferiority_desc>
            <param_type>Adjusted geometric mean ratio (%)</param_type>
            <param_value>108.39</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.094</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>93.081</ci_lower_limit>
            <ci_upper_limit>126.225</ci_upper_limit>
            <estimate_desc>Ratio calculated as T80-A5-H12.5 divided by T80-H12.5</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority limits: 80% - 125%</non_inferiority_desc>
            <param_type>Adjusted geometric mean ratio (%)</param_type>
            <param_value>114.86</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.097</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>98.216</ci_lower_limit>
            <ci_upper_limit>134.326</ci_upper_limit>
            <estimate_desc>Ratio calculated as T80-A5-H12.5 divided by T80-A5</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Plasma Concentration Curve at Steady State for Telmisartan</title>
        <description>Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau</description>
        <time_frame>15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration</time_frame>
        <population>PK set</population>
        <group_list>
          <group group_id="O1">
            <title>T80-A5-H12.5</title>
            <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.</description>
          </group>
          <group group_id="O2">
            <title>T80-A5</title>
            <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days</description>
          </group>
          <group group_id="O3">
            <title>T80-H12.5</title>
            <description>Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Curve at Steady State for Telmisartan</title>
          <description>Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau</description>
          <population>PK set</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2510" spread="72.1"/>
                    <measurement group_id="O2" value="2570" spread="70.8"/>
                    <measurement group_id="O3" value="2580" spread="81.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority limits: 80% - 125%</non_inferiority_desc>
            <param_type>Adjusted geometric mean ratio (%)</param_type>
            <param_value>97.53</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.05</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>90.43</ci_lower_limit>
            <ci_upper_limit>105.19</ci_upper_limit>
            <estimate_desc>Ratio calculated as T80-A5-H12.5 divided by T80-H12.5</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority limits: 80% - 125%</non_inferiority_desc>
            <param_type>Adjusted geometric mean ratio (%)</param_type>
            <param_value>102.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.03</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>96.94</ci_lower_limit>
            <ci_upper_limit>107.40</ci_upper_limit>
            <estimate_desc>Ratio calculated as T80-A5-H12.5 divided by T80-A5</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours</title>
        <description>Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state</description>
        <time_frame>0-6 hours (h), 6-12h and 12-24h after drug administration on day 10</time_frame>
        <population>PK set</population>
        <group_list>
          <group group_id="O1">
            <title>T80-A5-H12.5</title>
            <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.</description>
          </group>
          <group group_id="O2">
            <title>T80-H12.5</title>
            <description>Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours</title>
          <description>Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state</description>
          <population>PK set</population>
          <units>mg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" spread="11.4"/>
                    <measurement group_id="O2" value="9.9" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority limits: 80% - 125%</non_inferiority_desc>
            <param_type>Adjusted geometric mean ratio (%)</param_type>
            <param_value>104.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.016</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>101.949</ci_lower_limit>
            <ci_upper_limit>107.734</ci_upper_limit>
            <estimate_desc>Ratio calculated as T80-A5-H12.5 divided by T80-H12.5</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Measured Concentration (Cmax) at Steady State for Amlodipine</title>
        <description>Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau</description>
        <time_frame>15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration</time_frame>
        <population>PK set</population>
        <group_list>
          <group group_id="O1">
            <title>T80-A5-H12.5</title>
            <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.</description>
          </group>
          <group group_id="O2">
            <title>T80-A5</title>
            <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Measured Concentration (Cmax) at Steady State for Amlodipine</title>
          <description>Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau</description>
          <population>PK set</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" spread="21.8"/>
                    <measurement group_id="O2" value="11.3" spread="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority limits: 80% - 125%</non_inferiority_desc>
            <param_type>Adjusted geometric mean ratio (%)</param_type>
            <param_value>103.95</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.017</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>101.023</ci_lower_limit>
            <ci_upper_limit>106.964</ci_upper_limit>
            <estimate_desc>Ratio calculated as T80-A5-H12.5 divided by T80-A5</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Plasma Concentration Curve at Steady State for Amlodipine</title>
        <description>Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau</description>
        <time_frame>15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration</time_frame>
        <population>PK set</population>
        <group_list>
          <group group_id="O1">
            <title>T80-A5-H12.5</title>
            <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.</description>
          </group>
          <group group_id="O2">
            <title>T80-A5</title>
            <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Curve at Steady State for Amlodipine</title>
          <description>Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau</description>
          <population>PK set</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="230" spread="23.4"/>
                    <measurement group_id="O2" value="223" spread="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority limits: 80% - 125%</non_inferiority_desc>
            <param_type>Adjusted geometric mean ratio (%)</param_type>
            <param_value>102.49</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.014</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>100.167</ci_lower_limit>
            <ci_upper_limit>104.867</ci_upper_limit>
            <estimate_desc>Ratio calculated as T80-A5-H12.5 divided by T80-A5</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Measured Concentration (Cmax) at Steady State for HCTZ</title>
        <description>Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau</description>
        <time_frame>15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration</time_frame>
        <population>PK set</population>
        <group_list>
          <group group_id="O1">
            <title>T80-A5-H12.5</title>
            <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.</description>
          </group>
          <group group_id="O2">
            <title>T80-H12.5</title>
            <description>Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Measured Concentration (Cmax) at Steady State for HCTZ</title>
          <description>Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau</description>
          <population>PK set</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107" spread="28.5"/>
                    <measurement group_id="O2" value="102" spread="28.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority limits: 80% - 125%</non_inferiority_desc>
            <param_type>Adjusted geometric mean ratio (%)</param_type>
            <param_value>105.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.036</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.230</ci_lower_limit>
            <ci_upper_limit>111.847</ci_upper_limit>
            <estimate_desc>Ratio calculated as T80-A5-H12.5 divided by T80-H12.5</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Plasma Concentration Curve at Steady State for HCTZ</title>
        <description>Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau</description>
        <time_frame>15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration</time_frame>
        <population>PK set</population>
        <group_list>
          <group group_id="O1">
            <title>T80-A5-H12.5</title>
            <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.</description>
          </group>
          <group group_id="O2">
            <title>T80-H12.5</title>
            <description>Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Curve at Steady State for HCTZ</title>
          <description>Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau</description>
          <population>PK set</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="584" spread="23.8"/>
                    <measurement group_id="O2" value="565" spread="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority limits: 80% - 125%</non_inferiority_desc>
            <param_type>Adjusted geometric mean ratio (%)</param_type>
            <param_value>103.39</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.028</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>98.730</ci_lower_limit>
            <ci_upper_limit>108.280</ci_upper_limit>
            <estimate_desc>Ratio calculated as T80-A5-H12.5 divided by T80-H12.5</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>T80-A5-H12.5</title>
          <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.</description>
        </group>
        <group group_id="E2">
          <title>T80-H12.5</title>
          <description>Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days</description>
        </group>
        <group group_id="E3">
          <title>T80-A5</title>
          <description>Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days</description>
        </group>
        <group group_id="E4">
          <title>All Patients</title>
          <description>All participants in the study. Participants received three treatments in a randomised order&#xD;
T80-A5-H12.5&#xD;
T80-A5&#xD;
T80-H12.5</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02183675
org study id: 1348.5
nct id: NCT02183675
lead sponsor: 
To assess drug drug interaction through pharmacokinetics investigation at steady state of
      Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations
      in healthy Japanese male subjects
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Measured Concentration (Cmax) at Steady State for Telmisartan
time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration
description: Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau
measure: Area Under the Plasma Concentration Curve at Steady State for Telmisartan
time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration
description: Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau
measure: Maximum Measured Concentration (Cmax) at Steady State for Amlodipine
time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration
description: Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau
measure: Area Under the Plasma Concentration Curve at Steady State for Amlodipine
time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration
description: Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau
measure: Maximum Measured Concentration (Cmax) at Steady State for HCTZ
time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration
description: Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau
measure: Area Under the Plasma Concentration Curve at Steady State for HCTZ
time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration
description: Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau
measure: Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours
time frame: 0-6 hours (h), 6-12h and 12-24h after drug administration on day 10
description: Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state
arm group label: T/A/H
arm group type: Experimental
description: Telmisartan/Amlodipine/HCTZ fixed-dose combination
arm group label: T/A
arm group type: Active Comparator
description: Telmisartan/Amlodipine fixed-dose combination
arm group label: T/H
arm group type: Active Comparator
description: Telmisartan/HCTZ fixed-dose combination
intervention type: Drug
intervention name: Telmisartan/Amlodipine
description: Telmisartan/Amlodipine fixed-dose combination
arm group label: T/A
intervention type: Drug
intervention name: Telmisartan/Amlodipine/HCTZ
description: Telmisartan/Amlodipine/HCTZ fixed-dose combination
arm group label: T/A/H
intervention type: Drug
intervention name: Telmisartan/HCTZ
description: Telmisartan/HCTZ fixed-dose combination
arm group label: T/H
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Japan
url: http://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Amlodipine
mesh term: Telmisartan
mesh term: Hydrochlorothiazide
mesh term: Telmisartan amlodipine combination
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 