<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/NCT03042299</url>
  </required_header>
  <id_info>
    <org_study_id>Azilsartan-1004</org_study_id>
    <secondary_id>U1111-1190-0845</secondary_id>
    <secondary_id>JapicCTI-173503</secondary_id>
    <nct_id>NCT03042299</nct_id>
  </id_info>
  <brief_title>A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation</brief_title>
  <official_title>A Randomized, Open Label, 2-Period, 2-Treatment, Cross-over Phase 1 Study to Evaluate the Bio-equivalence of Single Oral Dose of TAK-536 Pediatric Formulation and TAK-536 Commercial Formulation in Healthy Adult Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the bio-equivalence of a single oral administration&#xD;
      of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial&#xD;
      formulation (tablet) in Japanese healthy adult male participants in an open label, 2-period,&#xD;
      2-treatment, cross-over design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the bio-equivalence of a single oral administration&#xD;
      of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial&#xD;
      formulation (tablet) in healthy adult male participants in an open label, 2-period,&#xD;
      2-treatment, cross-over design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">March 11, 2017</completion_date>
  <primary_completion_date type="Actual">March 11, 2017</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>AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-536</measure>
    <time_frame>Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax: Maximum Observed Plasma Concentration for TAK-536</measure>
    <time_frame>Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536</measure>
    <time_frame>Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536</measure>
    <time_frame>Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536</measure>
    <time_frame>Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Disposition Phase Rate Constant (λz) for TAK-536</measure>
    <time_frame>Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>Baseline up to Day 6 of Intervention Period 2 (Day 18)</time_frame>
    <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment or study participation. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs Related to Vital Signs</measure>
    <time_frame>Baseline up to Day 6 of Intervention Period 2 (Day 18)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs Related to Body Weight</measure>
    <time_frame>Baseline up to Day 6 of Intervention Period 2 (Day 18)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs Related to Electrocardiograms (ECGs)</measure>
    <time_frame>Baseline up to Day 6 of Intervention Period 2 (Day 18)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs Related to Clinical Laboratory Tests</measure>
    <time_frame>Baseline up to Day 6 of Intervention Period 2 (Day 18)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Japanese Healthy Adult Male Participants</condition>
  <arm_group>
    <arm_group_label>TAK-536 Granules + TAK-536 Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-536 10 milligram (mg), granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAK-536 Tablet + TAK-536 Granules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-536</intervention_name>
    <description>TAK-536 granules.</description>
    <arm_group_label>TAK-536 Granules + TAK-536 Tablet</arm_group_label>
    <arm_group_label>TAK-536 Tablet + TAK-536 Granules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-536</intervention_name>
    <description>TAK-536 tablet.</description>
    <arm_group_label>TAK-536 Granules + TAK-536 Tablet</arm_group_label>
    <arm_group_label>TAK-536 Tablet + TAK-536 Granules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. In the opinion of the investigator or sub-investigator, the participant is capable of&#xD;
             understanding and complying with protocol requirements.&#xD;
&#xD;
          2. Signs and dates a written, informed consent form prior to the initiation of any study&#xD;
             procedures.&#xD;
&#xD;
          3. Is a Japanese healthy adult male.&#xD;
&#xD;
          4. Aged 20 to 35 years, inclusive, at the time of informed consent.&#xD;
&#xD;
          5. Weighs at least 50.0 kilogram (kg), and has a body mass index (BMI) between 18.5 and&#xD;
             25.0 kilogram per square meter (kg/m^2), inclusive, at Screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has suspected hypotension with associated physical findings, such as dizziness&#xD;
             postural, facial pallor, or cold sweats based on evaluation/physical examination at&#xD;
             Screening, on the day before the study drug administration (Day -1) in Period 1, or up&#xD;
             to the study drug administration on the Period 1.&#xD;
&#xD;
          2. Has received any study drug within 16 weeks (112 days) prior to the study drug&#xD;
             administration in Period 1.&#xD;
&#xD;
          3. Has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic&#xD;
             agent.&#xD;
&#xD;
          4. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary,&#xD;
             hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other&#xD;
             abnormality, which may impact the ability of the participant to participate or&#xD;
             potentially confound the study results.&#xD;
&#xD;
          5. Has a known hypersensitivity to any component of the formulation of TAK-536 or any&#xD;
             angiotensin II receptor blocker (ARB).&#xD;
&#xD;
          6. Has a positive urine drug result for drugs of abuse (defined as any illicit drug use)&#xD;
             at Screening.&#xD;
&#xD;
          7. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol&#xD;
             abuse within 2 years prior to the Screening visit or is unwilling to agree to abstain&#xD;
             from alcohol and drugs throughout the study.&#xD;
&#xD;
          8. Has taken any excluded medication, supplements, dietary products, or food products&#xD;
             during the time periods specified in the protocol.&#xD;
&#xD;
          9. Has any current or recent (within 6 months) gastrointestinal diseases that would be&#xD;
             expected to influence the absorption of drugs (that is, a history of malabsorption,&#xD;
             esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once&#xD;
             per week] occurrence of heartburn, or any surgical intervention).&#xD;
&#xD;
         10. Has a history of cancer, except basal cell carcinoma which has been in remission for&#xD;
             at least 5 years prior to Day 1 of Period 1.&#xD;
&#xD;
         11. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus&#xD;
             (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological&#xD;
             reactions for syphilis at Screening.&#xD;
&#xD;
         12. Has poor peripheral venous access.&#xD;
&#xD;
         13. Has undergone whole blood collection of at least 200 milliliter (mL) within 4 weeks&#xD;
             (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of the study&#xD;
             drug administration in Period 1.&#xD;
&#xD;
         14. Has undergone whole blood collection of at least 800 mL in total within 52 weeks (364&#xD;
             days) prior to the start of the study drug administration in Period 1.&#xD;
&#xD;
         15. Has undergone blood component collection within 2 weeks (14 days) prior to the start&#xD;
             of the study drug administration in Period 1.&#xD;
&#xD;
         16. Has an abnormal (clinically significant) ECG at Screening or prior to the study drug&#xD;
             administration in Period 1.&#xD;
&#xD;
         17. Has abnormal laboratory values that suggest a clinically significant underlying&#xD;
             disease, or participant with the following laboratory abnormalities at Screening or&#xD;
             prior to the study drug administration in Period 1: alanine aminotransferase (ALT)&#xD;
             and/or aspartate aminotransferase (AST) greater than (&gt;) 1.5 * the upper limits of&#xD;
             normal (ULN).&#xD;
&#xD;
         18. Who, in the opinion of the investigator or sub-investigator, is unlikely to comply&#xD;
             with the protocol or is unsuitable for any other reason.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nishi Kumamoto Hospital</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <results_first_submitted>February 23, 2018</results_first_submitted>
  <results_first_submitted_qc>February 23, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 9, 2018</results_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug therapy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azilsartan medoxomil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03042299/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03042299/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 1 investigative site in Japan from 10 February 2017 to 11 March 2017.</recruitment_details>
      <pre_assignment_details>Healthy male participants were enrolled in 1 of the 2 treatment sequences of this 2-period cross-over study to receive TAK-536 10 milligram (mg) granules (pediatric formulation) or TAK-536 10 mg tablet (commercial formulation).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>TAK-536 Granules + TAK-536 Tablet</title>
          <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.</description>
        </group>
        <group group_id="P2">
          <title>TAK-536 Tablet + TAK-536 Granules</title>
          <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Intervention Period 1 (6 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period (at Least 6 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Intervention Period 2 (6 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety analysis set included all participants who received the study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>TAK-536 Granules + TAK-536 Tablet</title>
          <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.</description>
        </group>
        <group group_id="B2">
          <title>TAK-536 Tablet + TAK-536 Granules</title>
          <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.</description>
        </group>
        <group group_id="B3">
          <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="7"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.3" spread="0.95"/>
                    <measurement group_id="B2" value="21.3" spread="1.38"/>
                    <measurement group_id="B3" value="21.3" spread="1.14"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimeter (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="167.7" spread="3.64"/>
                    <measurement group_id="B2" value="171.3" spread="4.42"/>
                    <measurement group_id="B3" value="169.5" spread="4.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilogram (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.97" spread="5.586"/>
                    <measurement group_id="B2" value="60.49" spread="6.838"/>
                    <measurement group_id="B3" value="60.23" spread="6.005"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kilogram per square meter (kg/m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.33" spread="2.072"/>
                    <measurement group_id="B2" value="20.61" spread="2.143"/>
                    <measurement group_id="B3" value="20.97" spread="2.060"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking classification</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Never smoked</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current smoker</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ex-smoker</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol classification</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Drank a few times per week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drank a few times per month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Never drank</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Caffeine classification</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had caffeine consumption</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had no caffeine consumption</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-536</title>
        <time_frame>Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)</time_frame>
        <population>The pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-536 10 mg Granules (Pediatric Formulation)</title>
            <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>TAK-536 10 mg Tablet (Commercial Formulation)</title>
            <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-536</title>
          <population>The pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.</population>
          <units>hour*nanogram per milliliter (h*ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6053.7" spread="1119.60"/>
                    <measurement group_id="O2" value="6479.6" spread="1008.00"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The difference in the least square (LS) means between formulations (TAK-536 pediatric formulation [granules]-TAK-536 commercial formulation [tablet]) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included log-transformed (natural log) PK parameters AUC 48 as dependent variable, and formulation, group, and period as independent variables.</non_inferiority_desc>
            <param_type>Point estimate</param_type>
            <param_value>-0.0731</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1088</ci_lower_limit>
            <ci_upper_limit>-0.0373</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax: Maximum Observed Plasma Concentration for TAK-536</title>
        <time_frame>Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)</time_frame>
        <population>The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-536 10 mg Granules (Pediatric Formulation)</title>
            <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>TAK-536 10 mg Tablet (Commercial Formulation)</title>
            <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax: Maximum Observed Plasma Concentration for TAK-536</title>
          <population>The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="803.3" spread="113.63"/>
                    <measurement group_id="O2" value="878.1" spread="117.88"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The difference in the LS means between formulations (TAK-536 pediatric formulation [granules]-TAK-536 commercial formulation [tablet]) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and formulation, group, and period as independent variables.</non_inferiority_desc>
            <param_type>Point estimate</param_type>
            <param_value>-0.0909</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1573</ci_lower_limit>
            <ci_upper_limit>-0.0244</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536</title>
        <time_frame>Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)</time_frame>
        <population>The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-536 10 mg Granules (Pediatric Formulation)</title>
            <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>TAK-536 10 mg Tablet (Commercial Formulation)</title>
            <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536</title>
          <population>The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6187.4" spread="1167.72"/>
                    <measurement group_id="O2" value="6627.4" spread="1061.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536</title>
        <time_frame>Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)</time_frame>
        <population>The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-536 10 mg Granules (Pediatric Formulation)</title>
            <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>TAK-536 10 mg Tablet (Commercial Formulation)</title>
            <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536</title>
          <population>The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.89" spread="0.738"/>
                    <measurement group_id="O2" value="2.43" spread="0.958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536</title>
        <time_frame>Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)</time_frame>
        <population>The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-536 10 mg Granules (Pediatric Formulation)</title>
            <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>TAK-536 10 mg Tablet (Commercial Formulation)</title>
            <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536</title>
          <population>The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.781" spread="1.4010"/>
                    <measurement group_id="O2" value="10.11" spread="1.1873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Disposition Phase Rate Constant (λz) for TAK-536</title>
        <time_frame>Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)</time_frame>
        <population>The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-536 10 mg Granules (Pediatric Formulation)</title>
            <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>TAK-536 10 mg Tablet (Commercial Formulation)</title>
            <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Disposition Phase Rate Constant (λz) for TAK-536</title>
          <population>The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.</population>
          <units>liter per hour (L/h)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06866" spread="0.0046324"/>
                    <measurement group_id="O2" value="0.06862" spread="0.0077457"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</title>
        <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment or study participation. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
        <time_frame>Baseline up to Day 6 of Intervention Period 2 (Day 18)</time_frame>
        <population>The safety analysis set included all participants who received the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-536 10 mg Granules (Pediatric Formulation)</title>
            <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>TAK-536 10 mg Tablet (Commercial Formulation)</title>
            <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</title>
          <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment or study participation. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
          <population>The safety analysis set included all participants who received the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs Related to Vital Signs</title>
        <time_frame>Baseline up to Day 6 of Intervention Period 2 (Day 18)</time_frame>
        <population>The safety analysis set included all the participants who received the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-536 10 mg Granules (Pediatric Formulation)</title>
            <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>TAK-536 10 mg Tablet (Commercial Formulation)</title>
            <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs Related to Vital Signs</title>
          <population>The safety analysis set included all the participants who received the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs Related to Body Weight</title>
        <time_frame>Baseline up to Day 6 of Intervention Period 2 (Day 18)</time_frame>
        <population>The safety analysis set included all the participants who received the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-536 10 mg Granules (Pediatric Formulation)</title>
            <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>TAK-536 10 mg Tablet (Commercial Formulation)</title>
            <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs Related to Body Weight</title>
          <population>The safety analysis set included all the participants who received the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs Related to Electrocardiograms (ECGs)</title>
        <time_frame>Baseline up to Day 6 of Intervention Period 2 (Day 18)</time_frame>
        <population>The safety analysis set included all the participants who received the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-536 10 mg Granules (Pediatric Formulation)</title>
            <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>TAK-536 10 mg Tablet (Commercial Formulation)</title>
            <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs Related to Electrocardiograms (ECGs)</title>
          <population>The safety analysis set included all the participants who received the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs Related to Clinical Laboratory Tests</title>
        <time_frame>Baseline up to Day 6 of Intervention Period 2 (Day 18)</time_frame>
        <population>The safety analysis set included all the participants who received the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-536 10 mg Granules (Pediatric Formulation)</title>
            <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>TAK-536 10 mg Tablet (Commercial Formulation)</title>
            <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs Related to Clinical Laboratory Tests</title>
          <population>The safety analysis set included all the participants who received the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>TEAEs were assessed after the first dose of study drug until the follow up examination on Day 6 in Intervention Period 2 (Day 18)</time_frame>
      <desc>At each visit the investigator or sub-investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator or sub-investigator was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>TAK-536 10 mg Granules (Pediatric Formulation)</title>
          <description>TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
        </group>
        <group group_id="E2">
          <title>TAK-536 10 mg Tablet (Commercial Formulation)</title>
          <description>TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </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>Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>trialdisclosures@takeda.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/NCT03042299
org study id: Azilsartan-1004
secondary id: U1111-1190-0845
secondary id: JapicCTI-173503
nct id: NCT03042299
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the bio-equivalence of a single oral administration
      of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial
      formulation (tablet) in Japanese healthy adult male participants in an open label, 2-period,
      2-treatment, cross-over design.
The purpose of this study is to evaluate the bio-equivalence of a single oral administration
      of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial
      formulation (tablet) in healthy adult male participants in an open label, 2-period,
      2-treatment, cross-over design.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-536
time frame: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
measure: Cmax: Maximum Observed Plasma Concentration for TAK-536
time frame: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536
time frame: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536
time frame: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
measure: MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536
time frame: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
measure: Terminal Disposition Phase Rate Constant (λz) for TAK-536
time frame: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
time frame: Baseline up to Day 6 of Intervention Period 2 (Day 18)
description: An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment or study participation. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
measure: Number of Participants With TEAEs Related to Vital Signs
time frame: Baseline up to Day 6 of Intervention Period 2 (Day 18)
measure: Number of Participants With TEAEs Related to Body Weight
time frame: Baseline up to Day 6 of Intervention Period 2 (Day 18)
measure: Number of Participants With TEAEs Related to Electrocardiograms (ECGs)
time frame: Baseline up to Day 6 of Intervention Period 2 (Day 18)
measure: Number of Participants With TEAEs Related to Clinical Laboratory Tests
time frame: Baseline up to Day 6 of Intervention Period 2 (Day 18)
arm group label: TAK-536 Granules + TAK-536 Tablet
arm group type: Experimental
description: TAK-536 10 milligram (mg), granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
arm group label: TAK-536 Tablet + TAK-536 Granules
arm group type: Experimental
description: TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
intervention type: Drug
intervention name: TAK-536
description: TAK-536 granules.
arm group label: TAK-536 Granules + TAK-536 Tablet
arm group label: TAK-536 Tablet + TAK-536 Granules
intervention type: Drug
intervention name: TAK-536
description: TAK-536 tablet.
arm group label: TAK-536 Granules + TAK-536 Tablet
arm group label: TAK-536 Tablet + TAK-536 Granules
criteria: 
gender: Male
gender based: Yes
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Study Director
role: Study Director
affiliation: Takeda
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Azilsartan medoxomil
sharing ipd: Yes
ipd description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 