<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/NCT03010631</url>
  </required_header>
  <id_info>
    <org_study_id>SCMP-0211-304</org_study_id>
    <nct_id>NCT03010631</nct_id>
  </id_info>
  <brief_title>Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers</brief_title>
  <official_title>Comparative Pharmacokinetics and Food-Effect Bioavailability of a Sprinkle Formulation of Lubiprostone After Oral Administration in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sucampo Pharma Americas, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mallinckrodt</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle&#xD;
      formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To compare the pharmacokinetics of the sprinkle formulation of lubiprostone, as compared to&#xD;
      lubiprostone capsules and to determine the effect of food on the bioavailability and plasma&#xD;
      pharmacokinetics of lubiprostone sprinkle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">December 23, 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From the first dose of study drug up to 28 days</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Cohort 1 (Treatment Sequence AB)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 1: Treatment A. Capsule Fasted (7-day Washout) then Treatment B. Sprinkle Formulation, Fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1 (Treatment Sequence BA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 1: Treatment B. Sprinkle Formulation, Fasted (7-day Washout) then Treatment A. Capsule Fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 (Treatment Sequence CD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 2: Treatment C: Sprinkle Formulation, Fed (7-day Washout) then Treatment D: Sprinkle Formulation, Fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 (Treatment Sequence DC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 2: Treatment D: Sprinkle Formulation, Fasted (7-day Washout) then Treatment C. Sprinkle Formulation, Fed</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 1: Lubiprostone Capsule, Fasted</intervention_name>
    <description>Lubiprostone soft gelatin capsule administered under fasted conditions</description>
    <arm_group_label>Cohort 1 (Treatment Sequence AB)</arm_group_label>
    <arm_group_label>Cohort 1 (Treatment Sequence BA)</arm_group_label>
    <other_name>AMITIZA®</other_name>
    <other_name>Treatment A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 1: Lubiprostone Sprinkle Formulation, Fasted</intervention_name>
    <description>Lubiprostone sprinkle formulation administered under fasted conditions</description>
    <arm_group_label>Cohort 1 (Treatment Sequence AB)</arm_group_label>
    <arm_group_label>Cohort 1 (Treatment Sequence BA)</arm_group_label>
    <other_name>Lubiprostone microbeads</other_name>
    <other_name>Treatment B</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 2: Lubiprostone Sprinkle Formulation, Fed</intervention_name>
    <description>Lubiprostone sprinkle formulation administered under fed conditions</description>
    <arm_group_label>Cohort 2 (Treatment Sequence CD)</arm_group_label>
    <arm_group_label>Cohort 2 (Treatment Sequence DC)</arm_group_label>
    <other_name>Lubiprostone microbeads</other_name>
    <other_name>Treatment C</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 2: Lubiprostone Sprinkle Formulation, Fasted</intervention_name>
    <description>Lubiprostone sprinkle formulation administered under fasted conditions</description>
    <arm_group_label>Cohort 2 (Treatment Sequence CD)</arm_group_label>
    <arm_group_label>Cohort 2 (Treatment Sequence DC)</arm_group_label>
    <other_name>Lubiprostone microbeads</other_name>
    <other_name>Treatment D</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is male or female, between 18 and 55 years of age, inclusive.&#xD;
&#xD;
          -  Has a 12-lead electrocardiogram (ECG) within normal limits and is in good health based&#xD;
             upon review of medical history, physical examination results, vital signs (within&#xD;
             normal range), and normal laboratory profile for both blood and urine.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has an active or recent history of alcoholism or drug addiction (within 1 year prior)&#xD;
&#xD;
          -  Is a smoker or has a recent history of smoking (within 6 months)&#xD;
&#xD;
          -  Routinely consumes food known to alter drug metabolism (i.e., grapefruit juice,&#xD;
             coffee, tea, cola, chocolate, cocoa, or other caffeine or methyl-xanthine containing&#xD;
             foods or beverages) and/or cannot refrain from these items&#xD;
&#xD;
          -  Has donated blood within 3 months&#xD;
&#xD;
          -  Has a medical/surgical condition that might interfere with the absorption,&#xD;
             distribution, metabolism, or excretion of the study medication.&#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>Global Clinical Leader</last_name>
    <role>Study Director</role>
    <affiliation>Mallinckrodt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ICON</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <results_first_submitted>December 6, 2019</results_first_submitted>
  <results_first_submitted_qc>February 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 9, 2020</results_first_posted>
  <disposition_first_submitted>March 22, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>March 26, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 29, 2018</disposition_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lubiprostone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All participants were recruited in the United States</recruitment_details>
      <pre_assignment_details>Treatment periods for Cohorts 1 and 2 did not have the same participants.&#xD;
Participants in each cohort were randomized to sequence.&#xD;
In each sequence the first treatment was given for 14 days, there was a 7-day washout period, and then the second treatment was given for 14 days.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1: Treatment A Then Treatment B</title>
          <description>Participants in Cohort 1 who received Treatment A: Lubiprostone Capsule, Fasted for 14 days, followed (after a 7-day washout) by Treatment B: Sprinkle Formulation, Fasted for 14 days</description>
        </group>
        <group group_id="P2">
          <title>Cohort 1: Treatment B Then Treatment A</title>
          <description>Participants in Cohort 1 who received Treatment B: Sprinkle Formulation, Fasted for 14 days, followed (after a 7-day washout) by Treatment A: Lubiprostone Capsule, Fasted for 14 days</description>
        </group>
        <group group_id="P3">
          <title>Cohort 2: Treatment C Then Treatment D</title>
          <description>Participants in Cohort 2 who received Treatment C: Sprinkle, Fed for 14 days, followed (after a 7-day washout) by Treatment D: Sprinkle Formulation, Fasted for 14 days</description>
        </group>
        <group group_id="P4">
          <title>Cohort 2: Treatment D Then Treatment C</title>
          <description>Participants in Cohort 2 who received Treatment D: Sprinkle Formulation, Fasted for 14 days, followed (after a 7-day washout) by Treatment C: Sprinkle, Fed for 14 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Cohort 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <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>Cohort 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="7">New participants were enrolled for Cohort 2</participants>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population, defined as all randomized participants who took at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1: Treatment A Then Treatment B</title>
          <description>Participants in Cohort 1 who received Treatment A: Lubiprostone Capsule, Fasted for 14 days, followed (after a 7-day washout) by Treatment B: Sprinkle Formulation, Fasted for 14 days</description>
        </group>
        <group group_id="B2">
          <title>Cohort 1: Treatment B Then Treatment A</title>
          <description>Participants in Cohort 1 who received Treatment B: Sprinkle Formulation, Fasted for 14 days, followed (after a 7-day washout) by Treatment A: Lubiprostone Capsule, Fasted for 14 days</description>
        </group>
        <group group_id="B3">
          <title>Cohort 2: Treatment C Then Treatment D</title>
          <description>Participants in Cohort 2 who received Treatment C: Sprinkle, Fed for 14 days, followed (after a 7-day washout) by Treatment D: Sprinkle Formulation, Fasted for 14 days</description>
        </group>
        <group group_id="B4">
          <title>Cohort 2: Treatment D Then Treatment C</title>
          <description>Participants in Cohort 2 who received Treatment D: Sprinkle Formulation, Fasted for 14 days, followed (after a 7-day washout) by Treatment C: Sprinkle, Fed for 14 days</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="18"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="7"/>
            <count group_id="B4" value="7"/>
            <count group_id="B5" value="49"/>
          </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="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="49"/>
                  </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="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="22"/>
                  </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="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="23"/>
                  </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="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="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>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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="36"/>
                  </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>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite</title>
        <time_frame>1 day</time_frame>
        <population>PK population, defined as those with plasma concentration of lubiprostone or M3 sufficient to calculate at least 1 PK parameter</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A: Lubiprostone Capsule, Fasted</title>
            <description>Participants in the pharmacokinetic-evaluable (PK) population who received treatment A</description>
          </group>
          <group group_id="O2">
            <title>Treatment B: Sprinkle Formulation, Fasted</title>
            <description>Participants in the PK population who received treatment B</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite</title>
          <population>PK population, defined as those with plasma concentration of lubiprostone or M3 sufficient to calculate at least 1 PK parameter</population>
          <units>h*pg/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="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.518" spread="57.56"/>
                    <measurement group_id="O2" value="163.615" spread="47.45"/>
                  </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>Superiority</non_inferiority_type>
            <param_type>Ratio of Geometric LS Means</param_type>
            <param_value>1.441</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.166</ci_lower_limit>
            <ci_upper_limit>1.782</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite</title>
        <time_frame>1 day</time_frame>
        <population>Evaluable PK Population included all participants in the PK Population who had sufficient plasma drug concentration data of either lubiprostone or M3 to calculate at least 1 evaluable PK parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A: Lubiprostone Capsule, Fasted</title>
            <description>Cohort 1 participants who received Treatment A</description>
          </group>
          <group group_id="O2">
            <title>Treatment B: Sprinkle Formulation, Fasted</title>
            <description>Cohort 1 participants who received Treatment B</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite</title>
          <population>Evaluable PK Population included all participants in the PK Population who had sufficient plasma drug concentration data of either lubiprostone or M3 to calculate at least 1 evaluable PK parameter.</population>
          <units>pg/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="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.463" spread="55.56"/>
                    <measurement group_id="O2" value="127.729" spread="61.32"/>
                  </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>Superiority</non_inferiority_type>
            <param_type>Ratio of Geometric LS Means</param_type>
            <param_value>2.045</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.615</ci_lower_limit>
            <ci_upper_limit>2.589</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition</title>
        <time_frame>1 day</time_frame>
        <population>PK Evaluable Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment C: Sprinkle Formulation, Fed</title>
            <description>Cohort 2 participants who received Treatment C</description>
          </group>
          <group group_id="O2">
            <title>Treatment D: Sprinkle Formulation, Fasted</title>
            <description>Cohort 2 participants who received Treatment D</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition</title>
          <population>PK Evaluable Population.</population>
          <units>h*pg/mL</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135.805" spread="58.17"/>
                    <measurement group_id="O2" value="152.900" spread="26.96"/>
                  </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>Other</non_inferiority_type>
            <param_type>Ratio of Geometric LS Means</param_type>
            <param_value>0.888</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.675</ci_lower_limit>
            <ci_upper_limit>1.168</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions</title>
        <time_frame>1 day</time_frame>
        <population>PK Evaluable Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment C: Sprinkle Formulation, Fed</title>
            <description>Cohort 2 participants who received Treatment C</description>
          </group>
          <group group_id="O2">
            <title>Treatment D: Sprinkle Formulation, Fasted</title>
            <description>Cohort 2 participants who received Treatment D</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions</title>
          <population>PK Evaluable Population.</population>
          <units>pg/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="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.192" spread="30.52"/>
                    <measurement group_id="O2" value="116.815" spread="31.93"/>
                  </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>Other</non_inferiority_type>
            <param_type>Ratio of Geometric LS Means</param_type>
            <param_value>0.413</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.339</ci_lower_limit>
            <ci_upper_limit>0.502</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.</description>
        <time_frame>From the first dose of study drug up to 28 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A: Lubiprostone Capsule, Fasted</title>
            <description>Cohort 1 participants who received Treatment A</description>
          </group>
          <group group_id="O2">
            <title>Treatment B: Sprinkle Formulation, Fasted</title>
            <description>Cohort 1 participants who received Treatment B</description>
          </group>
          <group group_id="O3">
            <title>Treatment C: Sprinkle Formulation, Fed</title>
            <description>Cohort 2 participants who received Treatment C</description>
          </group>
          <group group_id="O4">
            <title>Treatment D: Sprinkle Formulation, Fasted</title>
            <description>Cohort 2 participants who received Treatment D</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Adverse Events</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 first dose of study drug up to 28 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment A</title>
          <description>All participants who received lubiprostone 2x24 μg capsule once orally.</description>
        </group>
        <group group_id="E2">
          <title>Treatment B</title>
          <description>All participants who received lubiprostone 2x24 μg sprinkle formulation once orally.</description>
        </group>
        <group group_id="E3">
          <title>Treatment C</title>
          <description>All participants who received lubiprostone 2x24 μg sprinkle formulation once orally under fed conditions.</description>
        </group>
        <group group_id="E4">
          <title>Treatment D</title>
          <description>All participants who received lubiprostone 2x24 μg sprinkle formulation once orally under fasted conditions.</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="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.1)</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="13" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Postural orthostatic tachycardia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <limitations_and_caveats>Because AUC0-∞ could only be determined in a limited number of participants, AUC0-t was used for primary comparisons.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Medical Information Call Center</name_or_title>
      <organization>Mallinckrodt Pharmaceuticals</organization>
      <phone>800-556-3314</phone>
      <email>clinicaltrials@mnk.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/NCT03010631
org study id: SCMP-0211-304
nct id: NCT03010631
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle
      formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
To compare the pharmacokinetics of the sprinkle formulation of lubiprostone, as compared to
      lubiprostone capsules and to determine the effect of food on the bioavailability and plasma
      pharmacokinetics of lubiprostone sprinkle.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite
time frame: 1 day
measure: Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite
time frame: 1 day
measure: Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition
time frame: 1 day
measure: Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions
time frame: 1 day
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: From the first dose of study drug up to 28 days
description: An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.
arm group label: Cohort 1 (Treatment Sequence AB)
arm group type: Active Comparator
description: Cohort 1: Treatment A. Capsule Fasted (7-day Washout) then Treatment B. Sprinkle Formulation, Fasted
arm group label: Cohort 1 (Treatment Sequence BA)
arm group type: Experimental
description: Cohort 1: Treatment B. Sprinkle Formulation, Fasted (7-day Washout) then Treatment A. Capsule Fasted
arm group label: Cohort 2 (Treatment Sequence CD)
arm group type: Experimental
description: Cohort 2: Treatment C: Sprinkle Formulation, Fed (7-day Washout) then Treatment D: Sprinkle Formulation, Fasted
arm group label: Cohort 2 (Treatment Sequence DC)
arm group type: Experimental
description: Cohort 2: Treatment D: Sprinkle Formulation, Fasted (7-day Washout) then Treatment C. Sprinkle Formulation, Fed
intervention type: Drug
intervention name: Cohort 1: Lubiprostone Capsule, Fasted
description: Lubiprostone soft gelatin capsule administered under fasted conditions
arm group label: Cohort 1 (Treatment Sequence AB)
arm group label: Cohort 1 (Treatment Sequence BA)
other name: AMITIZA®
other name: Treatment A
intervention type: Drug
intervention name: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted
description: Lubiprostone sprinkle formulation administered under fasted conditions
arm group label: Cohort 1 (Treatment Sequence AB)
arm group label: Cohort 1 (Treatment Sequence BA)
other name: Lubiprostone microbeads
other name: Treatment B
intervention type: Drug
intervention name: Cohort 2: Lubiprostone Sprinkle Formulation, Fed
description: Lubiprostone sprinkle formulation administered under fed conditions
arm group label: Cohort 2 (Treatment Sequence CD)
arm group label: Cohort 2 (Treatment Sequence DC)
other name: Lubiprostone microbeads
other name: Treatment C
intervention type: Drug
intervention name: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted
description: Lubiprostone sprinkle formulation administered under fasted conditions
arm group label: Cohort 2 (Treatment Sequence CD)
arm group label: Cohort 2 (Treatment Sequence DC)
other name: Lubiprostone microbeads
other name: Treatment D
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Global Clinical Leader
role: Study Director
affiliation: Mallinckrodt
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lubiprostone
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Because AUC0-∞ could only be determined in a limited number of participants, AUC0-t was used for primary comparisons.
point of contact: 