<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/NCT03801148</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-390MR-1002</org_study_id>
    <secondary_id>U1111-1224-9781</secondary_id>
    <nct_id>NCT03801148</nct_id>
  </id_info>
  <brief_title>A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules</brief_title>
  <official_title>A Phase 1, Randomized, Open-Label, Single-Center, Single-Dose, Two-Period, Two-Part Crossover Study in Healthy Subjects to Compare the Bioavailability of Dexlansoprazole From Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda GmbH Plant Oranienburg Relative to Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda Pharmaceutical Company Limited Osaka Plant Following a High-Fat Meal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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 assess the BA of 30 or 60 milligram (mg) dexlansoprazole&#xD;
      capsule manufactured at TOB (Takeda GmbH Plant Oranienburg) to the corresponding 30 or 60 mg&#xD;
      dexlansoprazole manufactured at TPC (Takeda Pharmaceutical Company Ltd.).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being&#xD;
      tested in healthy participants to compare the BA of dexlansoprazole capsules manufactured by&#xD;
      TOB relative to dexlansoprazole capsules manufactured by TPC, under fed conditions. The study&#xD;
      consists of two parts: Part 1 participants will receive dexlansoprazole 30 mg capsules&#xD;
      manufactured by TOB and TPC in a crossover fashion; Part 2 participants will receive&#xD;
      dexlansoprazole 60 mg capsules manufactured by TOB and TPC in a crossover fashion.&#xD;
&#xD;
      The study will enroll approximately 120 participants. Participants will be randomly assigned&#xD;
      (by chance, like flipping a coin) to 1 of the 4 treatment sequences as following:&#xD;
&#xD;
        -  Part 1: Dexlansoprazole 30 mg (TOB) + Dexlansoprazole 30 mg (TPC)&#xD;
&#xD;
        -  Part 1: Dexlansoprazole 30 mg (TPC) + Dexlansoprazole 30 mg (TOB)&#xD;
&#xD;
        -  Part 2: Dexlansoprazole 60 mg (TOB) + Dexlansoprazole 60 mg (TPC)&#xD;
&#xD;
        -  Part 2: Dexlansoprazole 60 mg (TPC) + Dexlansoprazole 60 mg (TOB)&#xD;
&#xD;
      All participants will be asked to take capsule of assigned dexlansoprazole on Day 1, 30&#xD;
      minutes following the beginning of a high-fat/high calorie breakfast of each treatment&#xD;
      period.&#xD;
&#xD;
      This single center trial will be conducted in the United States. The overall time to&#xD;
      participate in this study is approximately 86 days. Participants will be contacted by phone&#xD;
      call approximately 10 days after the last dose of study drug for a follow-up assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">April 9, 2019</completion_date>
  <primary_completion_date type="Actual">February 25, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 24 hours) post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 24 hours) post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0_infobs: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for Dexlansoprazole</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 24 hours) post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0_infpred: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Predicted Value of the Last Quantifiable Concentration for Dexlansoprazole</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 24 hours) post dose</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A [test]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B [reference]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B [reference]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A [test]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C [test]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D [reference]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D [reference]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C [test]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>30 mg dexlansoprazole capsules manufactured at TOB</intervention_name>
    <description>Dexlansoprazole delayed-release capsules.</description>
    <arm_group_label>Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC)</arm_group_label>
    <arm_group_label>Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>30 mg dexlansoprazole capsules manufactured at TPC</intervention_name>
    <description>Dexlansoprazole delayed-release capsules.</description>
    <arm_group_label>Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC)</arm_group_label>
    <arm_group_label>Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>60 mg dexlansoprazole capsules manufactured at TOB</intervention_name>
    <description>Dexlansoprazole delayed-release capsules.</description>
    <arm_group_label>Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC)</arm_group_label>
    <arm_group_label>Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>60 mg dexlansoprazole capsules manufactured at TPC</intervention_name>
    <description>Dexlansoprazole delayed-release capsules.</description>
    <arm_group_label>Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC)</arm_group_label>
    <arm_group_label>Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Has a body mass index (BMI) from 18 to 30 kilogram per square meter (kg/m^2), at&#xD;
             Screening.&#xD;
&#xD;
          2. Is willing and able to consume the high-fat/high-calorie breakfast administered during&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has a history of drug abuse (defined as any illicit drug use) or drug addiction in the&#xD;
             12 months prior to Screening or a history of alcohol abuse (defined as regular&#xD;
             consumption exceeding 21 units per week [1 unit equal (=) 12 ounces (oz) beer, 1.5 oz&#xD;
             hard liquor, or 5 oz wine]) within 1 year prior to the Screening Visit, or is&#xD;
             unwilling to agree to abstain from alcohol and drugs throughout the study.&#xD;
&#xD;
          2. Has a positive test result for drugs of abuse (defined as any illicit drug use) or&#xD;
             alcohol at Screening or Check-in (Day -1 of Period 1).&#xD;
&#xD;
          3. Has received any known hepatic or renal clearance altering agents (example,&#xD;
             erythromycin, cimetidine, barbiturates, phenothiazines, fluvoxamine, etc) for a period&#xD;
             of 28 days prior to Day 1 of Period 1.&#xD;
&#xD;
          4. Has donated blood products (such as plasma) within 30 days or has donated whole blood&#xD;
             or lost 450 milliliter (mL) or more of his or her blood volume, or had a transfusion&#xD;
             of any blood product within 56 days prior to Day 1 of Period 1.&#xD;
&#xD;
          5. With the exception of acetaminophen, the subject has taken any excluded medication,&#xD;
             supplements, or food products or beverages containing grapefruit or grapefruit juice,&#xD;
             star fruit or star fruit juice, Seville-type (sour) oranges and marmalade, apple,&#xD;
             orange, or pineapple juice, vegetables from the mustard green family (example, kale,&#xD;
             broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and&#xD;
             charbroiled meats. Hormonal contraception and hormone replacement therapy are allowed,&#xD;
             as long as the subject has been on a stable dose for a minimum of 90 days prior to Day&#xD;
             1 of Period 1.&#xD;
&#xD;
          6. Has used nicotine-containing products (including but not limited to cigarettes, pipes,&#xD;
             cigars, chewing tobacco, nicotine patch nicotine gum, e-cigarettes) within 28 days&#xD;
             prior to Check-in (Day -1 of Period 1), or has a positive cotinine test at Screening&#xD;
             or Check-in (Day -1 of Period 1), or is unwilling to abstain from these products for&#xD;
             the duration of the study.&#xD;
&#xD;
          7. Has received dexlansoprazole or lansoprazole in a previous clinical study or as a&#xD;
             therapeutic agent within 6 months of screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <results_first_submitted>February 21, 2020</results_first_submitted>
  <results_first_submitted_qc>March 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 19, 2020</results_first_posted>
  <last_update_submitted>March 17, 2020</last_update_submitted>
  <last_update_submitted_qc>March 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2020</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>Dexlansoprazole</mesh_term>
    <mesh_term>Lansoprazole</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 for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com 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>January 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03801148/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>January 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03801148/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 the United States from 10 January 2019 to 09 April 2019.</recruitment_details>
      <pre_assignment_details>Healthy participants were enrolled in this 2-part and 2-way crossover study to receive dexlansoprazole 30 milligram (mg) capsules manufactured by Takeda GmbH Plant Oranienburg (TOB) and 30 mg capsules manufactured by Takeda Pharmaceutical Company Ltd. (TPC) in Part 1 and dexlansoprazole 60 mg capsules by TOB and 60 mg capsules by TPC in Part 2.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1: Dexlansoprazole 30 mg TOB + Dexlansoprazole 30 mg TPC</title>
          <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5-day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.</description>
        </group>
        <group group_id="P2">
          <title>Part 1: Dexlansoprazole 30 mg TPC + Dexlansoprazole 30 mg TOB</title>
          <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.</description>
        </group>
        <group group_id="P3">
          <title>Part 2: Dexlansoprazole 60 mg TOB + Dexlansoprazole 60 mg TPC</title>
          <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.</description>
        </group>
        <group group_id="P4">
          <title>Part 2: Dexlansoprazole 60 mg TPC + Dexlansoprazole 60 mg TOB</title>
          <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1 (2 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout Period (at Least 5 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="29"/>
                <participants group_id="P4" count="29"/>
              </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="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2 (2 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="29"/>
                <participants group_id="P4" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="29"/>
                <participants group_id="P4" count="29"/>
              </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>Follow-Up (12 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="29"/>
                <participants group_id="P4" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="28"/>
                <participants group_id="P4" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety set included all participants who enrolled into the study and received at least one dose of the study drug(s).</population>
      <group_list>
        <group group_id="B1">
          <title>Part 1: Dexlansoprazole 30 mg TOB + Dexlansoprazole 30 mg TPC</title>
          <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5-day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.</description>
        </group>
        <group group_id="B2">
          <title>Part 1: Dexlansoprazole 30 mg TPC + Dexlansoprazole 30 mg TOB</title>
          <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.</description>
        </group>
        <group group_id="B3">
          <title>Part 2: Dexlansoprazole 60 mg TOB + Dexlansoprazole 60 mg TPC</title>
          <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.</description>
        </group>
        <group group_id="B4">
          <title>Part 2: Dexlansoprazole 60 mg TPC + Dexlansoprazole 60 mg TOB</title>
          <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.</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="31"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="30"/>
            <count group_id="B5" value="122"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="30"/>
                    <measurement group_id="B5" value="122"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>
          <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="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="53"/>
                  </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="24"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="26"/>
                  </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>
          <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="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="111"/>
                  </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="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="30"/>
                    <measurement group_id="B5" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 24 hours) post dose</time_frame>
        <population>The pharmacokinetic (PK) evaluable set included all participants who enrolled into study and received at least one dose of study drug, were not discontinued from study and replaced with other participants, who completed PK sampling in both periods, complied sufficiently with protocol, and displayed evaluable PK profiles.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Dexlansoprazole 30 mg TOB</title>
            <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Dexlansoprazole 30 mg TPC</title>
            <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: Dexlansoprazole 60 mg TOB</title>
            <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
          <group group_id="O4">
            <title>Part 2: Dexlansoprazole 60 mg TPC</title>
            <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole</title>
          <population>The pharmacokinetic (PK) evaluable set included all participants who enrolled into study and received at least one dose of study drug, were not discontinued from study and replaced with other participants, who completed PK sampling in both periods, complied sufficiently with protocol, and displayed evaluable PK profiles.</population>
          <units>nanogram/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="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="610.1" spread="52.0"/>
                    <measurement group_id="O2" value="622.5" spread="49.9"/>
                    <measurement group_id="O3" value="1381" spread="45.3"/>
                    <measurement group_id="O4" value="1302" spread="50.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Natural log (ln)-transformed-Cmax, was analyzed using an analysis of variance (ANOVA) model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric least square mean (LSM) ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.</non_inferiority_desc>
            <param_type>Geometric LSM ratio</param_type>
            <param_value>0.9800</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9171</ci_lower_limit>
            <ci_upper_limit>1.0473</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>ln-transformed-Cmax, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.</non_inferiority_desc>
            <param_type>Geometric LSM ratio</param_type>
            <param_value>1.0737</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0025</ci_lower_limit>
            <ci_upper_limit>1.1501</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 24 hours) post dose</time_frame>
        <population>The PK evaluable set included all participants who enrolled into study and received at least one dose of study drug, were not discontinued from study and replaced with other participants, who completed PK sampling in both periods, complied sufficiently with protocol, and displayed evaluable PK profiles.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Dexlansoprazole 30 mg TOB</title>
            <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Dexlansoprazole 30 mg TPC</title>
            <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: Dexlansoprazole 60 mg TOB</title>
            <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
          <group group_id="O4">
            <title>Part 2: Dexlansoprazole 60 mg TPC</title>
            <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole</title>
          <population>The PK evaluable set included all participants who enrolled into study and received at least one dose of study drug, were not discontinued from study and replaced with other participants, who completed PK sampling in both periods, complied sufficiently with protocol, and displayed evaluable PK profiles.</population>
          <units>nanogram*hour per milliliter(ng*hour/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="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2881" spread="66.8"/>
                    <measurement group_id="O2" value="2756" spread="62.8"/>
                    <measurement group_id="O3" value="6608" spread="58.5"/>
                    <measurement group_id="O4" value="6278" spread="59.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.</non_inferiority_desc>
            <param_type>Geometric LSM ratio</param_type>
            <param_value>1.0455</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0070</ci_lower_limit>
            <ci_upper_limit>1.0855</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.</non_inferiority_desc>
            <param_type>Geometric LSM ratio</param_type>
            <param_value>1.0610</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0192</ci_lower_limit>
            <ci_upper_limit>1.1046</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0_infobs: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for Dexlansoprazole</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 24 hours) post dose</time_frame>
        <population>PK evaluable set: participants enrolled into study, received at least one dose of study drug, were not discontinued from study and replaced with other participants, completed PK sampling in both periods, complied sufficiently with protocol, displayed evaluable PK profiles. PK analysis population where data at specified time points was available.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Dexlansoprazole 30 mg TOB</title>
            <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Dexlansoprazole 30 mg TPC</title>
            <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: Dexlansoprazole 60 mg TOB</title>
            <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
          <group group_id="O4">
            <title>Part 2: Dexlansoprazole 60 mg TPC</title>
            <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0_infobs: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for Dexlansoprazole</title>
          <population>PK evaluable set: participants enrolled into study, received at least one dose of study drug, were not discontinued from study and replaced with other participants, completed PK sampling in both periods, complied sufficiently with protocol, displayed evaluable PK profiles. PK analysis population where data at specified time points was available.</population>
          <units>ng*hour/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="58"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2927" spread="66.2"/>
                    <measurement group_id="O2" value="2885" spread="63.9"/>
                    <measurement group_id="O3" value="6734" spread="60.3"/>
                    <measurement group_id="O4" value="6220" spread="56.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>ln-transformed- AUC0_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0_infobs.</non_inferiority_desc>
            <param_type>Geometric LSM ratio</param_type>
            <param_value>1.0553</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0186</ci_lower_limit>
            <ci_upper_limit>1.0933</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>ln-transformed- AUC0_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0_infobs.</non_inferiority_desc>
            <param_type>GMR</param_type>
            <param_value>1.0468</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0027</ci_lower_limit>
            <ci_upper_limit>1.0929</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0_infpred: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Predicted Value of the Last Quantifiable Concentration for Dexlansoprazole</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 24 hours) post dose</time_frame>
        <population>PK evaluable set: participants enrolled into study, received at least one dose of study drug, were not discontinued from study and replaced with other participants, completed PK sampling in both periods, complied sufficiently with protocol, displayed evaluable PK profiles. PK analysis population where data at specified time points was available.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Dexlansoprazole 30 mg TOB</title>
            <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: Dexlansoprazole 30 mg TPC</title>
            <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: Dexlansoprazole 60 mg TOB</title>
            <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
          <group group_id="O4">
            <title>Part 2: Dexlansoprazole 60 mg TPC</title>
            <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0_infpred: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Predicted Value of the Last Quantifiable Concentration for Dexlansoprazole</title>
          <population>PK evaluable set: participants enrolled into study, received at least one dose of study drug, were not discontinued from study and replaced with other participants, completed PK sampling in both periods, complied sufficiently with protocol, displayed evaluable PK profiles. PK analysis population where data at specified time points was available.</population>
          <units>ng*hour/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="58"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2926" spread="66.2"/>
                    <measurement group_id="O2" value="2884" spread="63.9"/>
                    <measurement group_id="O3" value="6733" spread="60.3"/>
                    <measurement group_id="O4" value="6217" spread="56.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>ln-transformed- AUC0_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0_infpred.</non_inferiority_desc>
            <param_type>Geometric LSM ratio</param_type>
            <param_value>1.0555</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0188</ci_lower_limit>
            <ci_upper_limit>1.0935</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>ln-transformed- AUC0_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0_infpred.</non_inferiority_desc>
            <param_type>Geometric LSM ratio</param_type>
            <param_value>1.0472</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0029</ci_lower_limit>
            <ci_upper_limit>1.0934</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 37)</time_frame>
      <desc>At each visit the 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 was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part 1: Dexlansoprazole 30 mg TOB</title>
          <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.</description>
        </group>
        <group group_id="E2">
          <title>Part 1: Dexlansoprazole 30 mg TPC</title>
          <description>Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2.</description>
        </group>
        <group group_id="E3">
          <title>Part 2: Dexlansoprazole 60 mg TOB</title>
          <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2.</description>
        </group>
        <group group_id="E4">
          <title>Part 2: Dexlansoprazole 60 mg TPC</title>
          <description>Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of 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="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (21.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="59"/>
              </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/NCT03801148
org study id: TAK-390MR-1002
secondary id: U1111-1224-9781
nct id: NCT03801148
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the BA of 30 or 60 milligram (mg) dexlansoprazole
      capsule manufactured at TOB (Takeda GmbH Plant Oranienburg) to the corresponding 30 or 60 mg
      dexlansoprazole manufactured at TPC (Takeda Pharmaceutical Company Ltd.).
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being
      tested in healthy participants to compare the BA of dexlansoprazole capsules manufactured by
      TOB relative to dexlansoprazole capsules manufactured by TPC, under fed conditions. The study
      consists of two parts: Part 1 participants will receive dexlansoprazole 30 mg capsules
      manufactured by TOB and TPC in a crossover fashion; Part 2 participants will receive
      dexlansoprazole 60 mg capsules manufactured by TOB and TPC in a crossover fashion.

      The study will enroll approximately 120 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to 1 of the 4 treatment sequences as following:

        -  Part 1: Dexlansoprazole 30 mg (TOB) + Dexlansoprazole 30 mg (TPC)

        -  Part 1: Dexlansoprazole 30 mg (TPC) + Dexlansoprazole 30 mg (TOB)

        -  Part 2: Dexlansoprazole 60 mg (TOB) + Dexlansoprazole 60 mg (TPC)

        -  Part 2: Dexlansoprazole 60 mg (TPC) + Dexlansoprazole 60 mg (TOB)

      All participants will be asked to take capsule of assigned dexlansoprazole on Day 1, 30
      minutes following the beginning of a high-fat/high calorie breakfast of each treatment
      period.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 86 days. Participants will be contacted by phone
      call approximately 10 days after the last dose of study drug for a follow-up assessment.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole
time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose
measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole
time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose
measure: AUC0_infobs: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for Dexlansoprazole
time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose
measure: AUC0_infpred: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Predicted Value of the Last Quantifiable Concentration for Dexlansoprazole
time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose
arm group label: Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC)
arm group type: Experimental
description: Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A [test]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B [reference]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.
arm group label: Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)
arm group type: Experimental
description: Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B [reference]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A [test]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.
arm group label: Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC)
arm group type: Experimental
description: Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C [test]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D [reference]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.
arm group label: Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)
arm group type: Experimental
description: Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D [reference]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C [test]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.
intervention type: Drug
intervention name: 30 mg dexlansoprazole capsules manufactured at TOB
description: Dexlansoprazole delayed-release capsules.
arm group label: Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC)
arm group label: Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)
intervention type: Drug
intervention name: 30 mg dexlansoprazole capsules manufactured at TPC
description: Dexlansoprazole delayed-release capsules.
arm group label: Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC)
arm group label: Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)
intervention type: Drug
intervention name: 60 mg dexlansoprazole capsules manufactured at TOB
description: Dexlansoprazole delayed-release capsules.
arm group label: Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC)
arm group label: Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)
intervention type: Drug
intervention name: 60 mg dexlansoprazole capsules manufactured at TPC
description: Dexlansoprazole delayed-release capsules.
arm group label: Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC)
arm group label: Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Takeda
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dexlansoprazole
mesh term: Lansoprazole
sharing ipd: Yes
ipd description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com 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: 