<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/NCT04501640</url>
  </required_header>
  <id_info>
    <org_study_id>178-MA-2294</org_study_id>
    <secondary_id>CTR20201670</secondary_id>
    <nct_id>NCT04501640</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants</brief_title>
  <official_title>A Phase 4 Open-label, Randomized, Single Oral Dose, Two-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Mirabegron in Healthy Chinese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma China, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of&#xD;
      mirabegron in healthy Chinese male and female participants.&#xD;
&#xD;
      This study also evaluated the safety and tolerability of single oral doses of mirabegron in&#xD;
      healthy Chinese male and female participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-label, randomized, 2-period, single oral dose crossover design at 2 dose levels in&#xD;
      healthy Chinese male and female participants. Each participant took part in 2 periods&#xD;
      separated by a washout of at least 10 days between investigational product (IP)&#xD;
      administrations in each period.&#xD;
&#xD;
      Participants were screened for up to 21 days prior to IP administration on day 1 of period 1.&#xD;
      Eligible participants were admitted to the clinical unit on day -1 of each period and were&#xD;
      confined until the last pharmacokinetic sample had been drawn within each period. PK samples&#xD;
      were collected predose on day 1 of each period and at multiple time points following each&#xD;
      dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Actual">October 27, 2020</completion_date>
  <primary_completion_date type="Actual">October 14, 2020</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>This was a two-way crossover design with 2 period and 2 dose groups. Participants were randomized to 1 of 4 sequences dependent on dose and period assigned.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This was an open label study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron</measure>
    <time_frame>Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period</time_frame>
    <description>AUCinf for mirabegron was reported for the plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron</measure>
    <time_frame>Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period</time_frame>
    <description>AUClast for mirabegron was reported for the plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Concentration (Cmax) For Mirabegron</measure>
    <time_frame>Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period</time_frame>
    <description>Cmax for mirabegron was reported from the plasma samples collected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AE)</measure>
    <time_frame>From date of informed consent signed to end of study (up to 24 days)</time_frame>
    <description>An AE is any untoward medical occurrence in a participant administered an study drug, and which does not necessarily have to have a causal relationship with this study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. An AE is considered &quot;serious&quot; if, in the view of either the investigator or sponsor, the event results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions results in congenital anomaly, or birth defect, requires inpatient hospitalization, other medically important AE. An AE with onset at any time from first dosing until last scheduled procedure was classified as a TEAE.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Pharmacokinetics of Mirabegron</condition>
  <condition>Food Effect</condition>
  <condition>Healthy Chinese Subjects</condition>
  <arm_group>
    <arm_group_label>Mirabegron 25 mg fed/Mirabegron 25 mg fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 25 milligram (mg) mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mirabegron 25 mg fasted/Mirabegron 25 mg fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mirabegron 50 mg fed/Mirabegron 50 mg fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mirabegron 50 mg fasted/Mirabegron 50 mg fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single dose of 50 mg mirabegron under fasted condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mirabegron</intervention_name>
    <description>Oral adminstration</description>
    <arm_group_label>Mirabegron 25 mg fasted/Mirabegron 25 mg fed</arm_group_label>
    <arm_group_label>Mirabegron 25 mg fed/Mirabegron 25 mg fasted</arm_group_label>
    <arm_group_label>Mirabegron 50 mg fasted/Mirabegron 50 mg fed</arm_group_label>
    <arm_group_label>Mirabegron 50 mg fed/Mirabegron 50 mg fasted</arm_group_label>
    <other_name>Betmiga</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a body mass index range of 19.0 to 24.9 kg/m^2, inclusive and weighs at&#xD;
             least 50 kg for male subjects and 45 kg for female subjects at screening.&#xD;
&#xD;
          -  Female subject is not pregnant and at least 1 of the following conditions apply:&#xD;
&#xD;
               -  Not a woman of childbearing potential (WOCBP)&#xD;
&#xD;
               -  WOCBP who agrees to follow the contraceptive guidance from the time of informed&#xD;
                  consent through at least 30 days after final IP administration&#xD;
&#xD;
          -  Female subject must agree not to breastfeed starting at screening and throughout the&#xD;
             study period and for 30 days after final IP administration.&#xD;
&#xD;
          -  Female subject must not donate ova starting at first dose of IP and throughout the&#xD;
             study period and for 30 days after final IP administration.&#xD;
&#xD;
          -  Male subject with female partner(s) of childbearing potential (including breastfeeding&#xD;
             partner[s]) must agree to use contraception throughout the study period and for 30&#xD;
             days after final IP administration.&#xD;
&#xD;
          -  Male subject must not donate sperm during the study period and for 30 days after final&#xD;
             IP administration.&#xD;
&#xD;
          -  Male subject with pregnant partner(s) must agree to remain abstinent or use a condom&#xD;
             for the duration of the pregnancy throughout the study period and for 30 days after&#xD;
             final IP administration.&#xD;
&#xD;
          -  Subject agrees not to participate in another interventional study while participating&#xD;
             in the present study, defined as 84 days prior screening until completion of the last&#xD;
             study visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female subject who has been pregnant within 6 months prior to screening or&#xD;
             breastfeeding within 3 months prior to screening.&#xD;
&#xD;
          -  Subject has a known or suspected hypersensitivity to mirabegron or any components of&#xD;
             the formulation used.&#xD;
&#xD;
          -  Subject has had previous exposure with mirabegron.&#xD;
&#xD;
          -  Subject has any of the liver function tests (alkaline phosphatase, alanine&#xD;
             aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase&#xD;
             and total bilirubin [TBL]) ≥ 1.5 × upper limit of normal (ULN) on day -1 of period 1.&#xD;
&#xD;
          -  Subject has any clinically significant history of allergic conditions (including drug&#xD;
             allergies, asthma, eczema or anaphylactic reactions, but excluding untreated,&#xD;
             asymptomatic, seasonal allergies) prior to first IP administration.&#xD;
&#xD;
          -  Subject has any history or evidence of any clinically significant cardiovascular,&#xD;
             gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic,&#xD;
             urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major&#xD;
             disease or malignancy.&#xD;
&#xD;
          -  Subject has/had febrile illness or symptomatic, viral, bacterial (including upper&#xD;
             respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day&#xD;
             -1 of period 1.&#xD;
&#xD;
          -  Subject has any of the following concerns with regard to tuberculosis:&#xD;
&#xD;
               -  History of active tuberculosis&#xD;
&#xD;
               -  Abnormalities detected in a chest X-ray on day -1 of period 1&#xD;
&#xD;
               -  Contact with infectious tuberculous patients&#xD;
&#xD;
          -  Subject has any clinically significant abnormality following the physical examination,&#xD;
             electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or&#xD;
             on day -1 of period 1.&#xD;
&#xD;
          -  Participant has a mean pulse &lt; 45 bpm, &gt; 99 bpm; mean body temperature &lt; 35.0°C, &gt;&#xD;
             37.5°C; mean systolic blood pressure &lt; 90 mmHg, ≥ 140 mmHg; mean diastolic blood&#xD;
             pressure &lt; 40 mmHg, ≥ 90 mmHg (measurements taken in triplicate after participant has&#xD;
             been resting in the supine position for at least 5 minutes) at screening or on day-1&#xD;
             of period 1. If the mean blood pressure exceeds the limits above, 1 additional&#xD;
             triplicate may be taken.&#xD;
&#xD;
          -  Participant has a mean corrected QT interval using Fridericia's formula (QTcF) of: ≥&#xD;
             430 msec (for male subjects) ≥ 450 msec (for female subjects) at screening or on day-1&#xD;
             of period 1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG&#xD;
             may be taken.&#xD;
&#xD;
          -  Subject has used any prescribed or nonprescribed drugs (including vitamins, natural&#xD;
             and herbal remedies, e.g., St. John's Wort and traditional Chinese medicine) in the 2&#xD;
             weeks prior to first IP administration, except for occasional use of paracetamol (up&#xD;
             to 2 g/day), topical dermatological products, including corticosteroid products,&#xD;
             hormonal contraceptives or hormone replacement therapy (HRT).&#xD;
&#xD;
          -  Subject has a history of smoking &gt; 10 cigarettes (or equivalent amount of tobacco) per&#xD;
             day within 3 months prior to day -1 of period 1.&#xD;
&#xD;
          -  Subject has a history of consuming &gt; 21 units for male subjects or &gt; 14 units for&#xD;
             female subjects of alcohol per week within 3 months prior to day -1 of period 1 (note:&#xD;
             1 unit = 10 g pure alcohol, 250 mL of beer [5%], 35 mL of spirits [35%] or 100 mL of&#xD;
             wine [12%]) or the subject has a history of alcohol-dependency, drug-dependency,&#xD;
             chemical-dependency, or alcohol or drug abuse within 2 years prior to screening or the&#xD;
             subject tests positive for alcohol at screening or on day -1 of period 1.&#xD;
&#xD;
          -  Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines,&#xD;
             cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 of period 1 or&#xD;
             the subject tests positive for drugs of abuse (amphetamines, benzodiazepines,&#xD;
             cannabinoids, cocaine and opiates) at screening or on day -1 of period 1.&#xD;
&#xD;
          -  Subject has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3&#xD;
             months prior to day -1 of period 1.&#xD;
&#xD;
          -  Subject has had significant blood loss, donated ≥ 400 mL of whole blood within 90&#xD;
             days, ≥ 200 mL of whole blood within 30 days or donated blood components within 14&#xD;
             days prior to day -1 of period 1 and/or received a transfusion of any blood or blood&#xD;
             products within 60 days.&#xD;
&#xD;
          -  Subject has a positive serology test for hepatitis A virus antibodies (immunoglobulin&#xD;
             M), hepatitis B core antibodies, hepatitis B surface antigen, hepatitis C virus&#xD;
             antibodies, human immunodeficiency virus or syphilis at screening.&#xD;
&#xD;
          -  Subject is an employee of Astellas, the study-related contract research organizations&#xD;
             or the clinical unit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Executive Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma China, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site CN86001</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrials.astellas.com/study/?pid=178-MA-2294</url>
    <description>Link to results and other applicable study documents on the Astellas Clinical Trials website</description>
  </link>
  <link>
    <url>https://www.trialsummaries.com/Study/StudyDetails?id=14527&amp;tenant=MT_AST_9011</url>
    <description>Link to plain language summary of the study on the Trial Results Summaries website</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <results_first_submitted>October 1, 2021</results_first_submitted>
  <results_first_submitted_qc>October 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 29, 2021</results_first_posted>
  <last_update_submitted>November 10, 2021</last_update_submitted>
  <last_update_submitted_qc>November 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mirabegron</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>two-way crossover</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mirabegron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</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>September 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT04501640/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>June 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT04501640/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at one site in China.</recruitment_details>
      <pre_assignment_details>Healthy Chinese female and male participants between 18 to 45 years of age, inclusive (at screening), and met all of the inclusion and none of the exclusion criteria were eligible to participate in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Mirabegron 25 mg Fed/Mirabegron 25 mg Fasted</title>
          <description>Participants received single dose of 25 milligrams (mg) mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.</description>
        </group>
        <group group_id="P2">
          <title>Mirabegron 25 mg Fasted/Mirabegron 25 mg Fed</title>
          <description>Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.</description>
        </group>
        <group group_id="P3">
          <title>Mirabegron 50 mg Fed/Mirabegron 50 mg Fasted</title>
          <description>Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.</description>
        </group>
        <group group_id="P4">
          <title>Mirabegron 50 mg Fasted/Mirabegron 50 mg Fed</title>
          <description>Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1 (5 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_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_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_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period (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_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_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_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2 (5 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_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_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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Mirabegron 25 mg Fed/Mirabegron 25 mg Fasted</title>
          <description>Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.</description>
        </group>
        <group group_id="B2">
          <title>Mirabegron 25 mg Fasted/Mirabegron 25 mg Fed</title>
          <description>Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.</description>
        </group>
        <group group_id="B3">
          <title>Mirabegron 50 mg Fed/Mirabegron 50 mg Fasted</title>
          <description>Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.</description>
        </group>
        <group group_id="B4">
          <title>Mirabegron 50 mg Fasted/Mirabegron 50 mg Fed</title>
          <description>Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.</description>
        </group>
        <group group_id="B5">
          <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="24"/>
          </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="27.8" spread="7.8"/>
                    <measurement group_id="B2" value="25.0" spread="4.8"/>
                    <measurement group_id="B3" value="26.7" spread="7.2"/>
                    <measurement group_id="B4" value="24.5" spread="3.7"/>
                    <measurement group_id="B5" value="26.0" spread="5.8"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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_list>
                </category>
                <category>
                  <title>Asian</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="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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_list>
                </category>
                <category>
                  <title>Black or African American</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_list>
                </category>
                <category>
                  <title>White</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_list>
                </category>
                <category>
                  <title>More than one race</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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron</title>
        <description>AUCinf for mirabegron was reported for the plasma samples collected.</description>
        <time_frame>Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period</time_frame>
        <population>The pharmacokinetic analysis set (PKAS) consisted of all participants who received at least 1 dose of investigational product (IP) for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Mirabegron 25 mg Fed</title>
            <description>Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron 25 mg Fasted</title>
            <description>Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
          <group group_id="O3">
            <title>Mirabegron 50 mg Fed</title>
            <description>Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
          <group group_id="O4">
            <title>Mirabegron 50 mg Fasted</title>
            <description>Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron</title>
          <description>AUCinf for mirabegron was reported for the plasma samples collected.</description>
          <population>The pharmacokinetic analysis set (PKAS) consisted of all participants who received at least 1 dose of investigational product (IP) for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
          <units>Hour*nanogram per milliliter (h*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="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.8" spread="37.2"/>
                    <measurement group_id="O2" value="143" spread="39.3"/>
                    <measurement group_id="O3" value="263" spread="26.9"/>
                    <measurement group_id="O4" value="429" spread="36.8"/>
                  </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>
            <groups_desc>Assessment based on an analysis of variance (ANOVA) performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geomteric Least Squares (LS) Mean Ratio</param_type>
            <param_value>57.06</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>46.21</ci_lower_limit>
            <ci_upper_limit>70.47</ci_upper_limit>
            <estimate_desc>Ratios and confidence intervals are transformed back to raw scale &amp; values are expressed as percentages.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric LSMean Ratio</param_type>
            <param_value>61.42</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>52.06</ci_lower_limit>
            <ci_upper_limit>72.47</ci_upper_limit>
            <estimate_desc>Ratios and confidence intervals are transformed back to raw scale &amp; values are expressed as percentages.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron</title>
        <description>AUClast for mirabegron was reported for the plasma samples collected.</description>
        <time_frame>Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period</time_frame>
        <population>PKAS Population</population>
        <group_list>
          <group group_id="O1">
            <title>Mirabegron 25 mg Fed</title>
            <description>Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron 25 mg Fasted</title>
            <description>Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
          <group group_id="O3">
            <title>Mirabegron 50 mg Fed</title>
            <description>Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
          <group group_id="O4">
            <title>Mirabegron 50 mg Fasted</title>
            <description>Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron</title>
          <description>AUClast for mirabegron was reported for the plasma samples collected.</description>
          <population>PKAS Population</population>
          <units>h*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="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.3" spread="36.8"/>
                    <measurement group_id="O2" value="119" spread="40.8"/>
                    <measurement group_id="O3" value="218" spread="25.4"/>
                    <measurement group_id="O4" value="369" spread="39.5"/>
                  </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>
            <groups_desc>Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geomteric LSMean Ratio</param_type>
            <param_value>53.31</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>43.02</ci_lower_limit>
            <ci_upper_limit>66.05</ci_upper_limit>
            <estimate_desc>Ratios and confidence intervals are transformed back to raw scale &amp; values are expressed as percentages.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geomteric LSMean Ratio</param_type>
            <param_value>59.14</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>49.48</ci_lower_limit>
            <ci_upper_limit>70.70</ci_upper_limit>
            <estimate_desc>Ratios and confidence intervals are transformed back to raw scale &amp; values are expressed as percentages.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Concentration (Cmax) For Mirabegron</title>
        <description>Cmax for mirabegron was reported from the plasma samples collected.</description>
        <time_frame>Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period</time_frame>
        <population>PKAS Population</population>
        <group_list>
          <group group_id="O1">
            <title>Mirabegron 25 mg Fed</title>
            <description>Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron 25 mg Fasted</title>
            <description>Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
          <group group_id="O3">
            <title>Mirabegron 50 mg Fed</title>
            <description>Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
          <group group_id="O4">
            <title>Mirabegron 50 mg Fasted</title>
            <description>Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Concentration (Cmax) For Mirabegron</title>
          <description>Cmax for mirabegron was reported from the plasma samples collected.</description>
          <population>PKAS Population</population>
          <units>Nanogram per milliliter (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="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.07" spread="29.9"/>
                    <measurement group_id="O2" value="7.88" spread="82.1"/>
                    <measurement group_id="O3" value="15.9" spread="47.7"/>
                    <measurement group_id="O4" value="33.3" spread="82.7"/>
                  </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>
            <groups_desc>Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric LSMean Ratio</param_type>
            <param_value>38.93</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>26.78</ci_lower_limit>
            <ci_upper_limit>56.59</ci_upper_limit>
            <estimate_desc>Ratios and confidence intervals are transformed back to raw scale &amp; values are expressed as percentages.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric LSMean Ratio</param_type>
            <param_value>47.90</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>31.76</ci_lower_limit>
            <ci_upper_limit>72.24</ci_upper_limit>
            <estimate_desc>Ratios and confidence intervals are transformed back to raw scale &amp; values are expressed as percentages.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AE)</title>
        <description>An AE is any untoward medical occurrence in a participant administered an study drug, and which does not necessarily have to have a causal relationship with this study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. An AE is considered &quot;serious&quot; if, in the view of either the investigator or sponsor, the event results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions results in congenital anomaly, or birth defect, requires inpatient hospitalization, other medically important AE. An AE with onset at any time from first dosing until last scheduled procedure was classified as a TEAE.</description>
        <time_frame>From date of informed consent signed to end of study (up to 24 days)</time_frame>
        <population>The safety analysis set (SAF) consisted of all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Mirabegron 25 mg Fed</title>
            <description>Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron 25 mg Fasted</title>
            <description>Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
          <group group_id="O3">
            <title>Mirabegron 50 mg Fed</title>
            <description>Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
          <group group_id="O4">
            <title>Mirabegron 50 mg Fasted</title>
            <description>Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AE)</title>
          <description>An AE is any untoward medical occurrence in a participant administered an study drug, and which does not necessarily have to have a causal relationship with this study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. An AE is considered &quot;serious&quot; if, in the view of either the investigator or sponsor, the event results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions results in congenital anomaly, or birth defect, requires inpatient hospitalization, other medically important AE. An AE with onset at any time from first dosing until last scheduled procedure was classified as a TEAE.</description>
          <population>The safety analysis set (SAF) consisted of all participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related TEAE Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE Leading to Withdrawal of Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related TEAE Leading to Withdrawal of Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From date of informed consent signed to end of study (up to 24 days)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mirabegron 25 mg Fed</title>
          <description>Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.</description>
        </group>
        <group group_id="E2">
          <title>Mirabegron 25 mg Fasted</title>
          <description>Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.</description>
        </group>
        <group group_id="E3">
          <title>Mirabegron 50 mg Fed</title>
          <description>Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.</description>
        </group>
        <group group_id="E4">
          <title>Mirabegron 50 mg Fasted</title>
          <description>Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v23.0</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="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Protein urine present</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </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>Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Disclosure</name_or_title>
      <organization>Astellas Pharma China, Inc.</organization>
      <phone>+86-(0)10-85216666</phone>
      <email>astellas.resultsdisclosure@astellas.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/NCT04501640
org study id: 178-MA-2294
secondary id: CTR20201670
nct id: NCT04501640
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of
      mirabegron in healthy Chinese male and female participants.

      This study also evaluated the safety and tolerability of single oral doses of mirabegron in
      healthy Chinese male and female participants.
An open-label, randomized, 2-period, single oral dose crossover design at 2 dose levels in
      healthy Chinese male and female participants. Each participant took part in 2 periods
      separated by a washout of at least 10 days between investigational product (IP)
      administrations in each period.

      Participants were screened for up to 21 days prior to IP administration on day 1 of period 1.
      Eligible participants were admitted to the clinical unit on day -1 of each period and were
      confined until the last pharmacokinetic sample had been drawn within each period. PK samples
      were collected predose on day 1 of each period and at multiple time points following each
      dose.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This was a two-way crossover design with 2 period and 2 dose groups. Participants were randomized to 1 of 4 sequences dependent on dose and period assigned.
primary purpose: Basic Science
masking: None (Open Label)
masking description: This was an open label study.
measure: Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron
time frame: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period
description: AUCinf for mirabegron was reported for the plasma samples collected.
measure: Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron
time frame: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period
description: AUClast for mirabegron was reported for the plasma samples collected.
measure: Maximum Concentration (Cmax) For Mirabegron
time frame: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period
description: Cmax for mirabegron was reported from the plasma samples collected.
measure: Number of Participants With Adverse Events (AE)
time frame: From date of informed consent signed to end of study (up to 24 days)
description: An AE is any untoward medical occurrence in a participant administered an study drug, and which does not necessarily have to have a causal relationship with this study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions results in congenital anomaly, or birth defect, requires inpatient hospitalization, other medically important AE. An AE with onset at any time from first dosing until last scheduled procedure was classified as a TEAE.
arm group label: Mirabegron 25 mg fed/Mirabegron 25 mg fasted
arm group type: Experimental
description: Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 25 milligram (mg) mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
arm group label: Mirabegron 25 mg fasted/Mirabegron 25 mg fed
arm group type: Experimental
description: Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
arm group label: Mirabegron 50 mg fed/Mirabegron 50 mg fasted
arm group type: Experimental
description: Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
arm group label: Mirabegron 50 mg fasted/Mirabegron 50 mg fed
arm group type: Experimental
description: Participants received single dose of 50 mg mirabegron under fasted condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
intervention type: Drug
intervention name: mirabegron
description: Oral adminstration
arm group label: Mirabegron 25 mg fasted/Mirabegron 25 mg fed
arm group label: Mirabegron 25 mg fed/Mirabegron 25 mg fasted
arm group label: Mirabegron 50 mg fasted/Mirabegron 50 mg fed
arm group label: Mirabegron 50 mg fed/Mirabegron 50 mg fasted
other name: Betmiga
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Executive Director
role: Study Director
affiliation: Astellas Pharma China, Inc.
facility: 
country: China
url: https://www.clinicaltrials.astellas.com/study/?pid=178-MA-2294
description: Link to results and other applicable study documents on the Astellas Clinical Trials website
url: https://www.trialsummaries.com/Study/StudyDetails?id=14527&tenant=MT_AST_9011
description: Link to plain language summary of the study on the Trial Results Summaries website
responsible party type: Sponsor
mesh term: Mirabegron
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 