<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/NCT01703858</url>
  </required_header>
  <id_info>
    <org_study_id>1314.3</org_study_id>
    <secondary_id>2012-002537-11</secondary_id>
    <nct_id>NCT01703858</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608</brief_title>
  <official_title>An Open Label, Randomised, Single Dose, 3-way Cross Over Study to Investigate Relative Bioavailability and Food Effect on Different Formulations of BI 113608 in Healthy Male Subjects, Followed by Fixed Sequence Periods Investigating Influence of Pantoprazole Coadministration and Food Effect on Pharmacokinetics of Different Formulations of BI 113608</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objective of the trial is to investigate the relative bioavailability, influence of&#xD;
      pantoprazole coadministration and food effect of different oral formulations of BI 113608 in&#xD;
      healthy male subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)</measure>
    <time_frame>PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.</time_frame>
    <description>Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)</measure>
    <time_frame>PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.</time_frame>
    <description>Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)</measure>
    <time_frame>PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.</time_frame>
    <description>Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>1 BI 113608</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>powder in the bottle for oral solution, oral administration with 240 mL water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 BI 113608</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>conventional tablet formulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 BI 113608</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>conventional tablet formulation, fed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4 BI 113608</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>conventional tablet after pantoprazole administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 BI 113608</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>conventional tablet formulation, fasted, 0:30 min before fat breakfast</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 113608 PIB</intervention_name>
    <description>powder for oral solution</description>
    <arm_group_label>1 BI 113608</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 113608</intervention_name>
    <description>conventional tablet formulation</description>
    <arm_group_label>2 BI 113608</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 113608</intervention_name>
    <description>conventional tablet formulation</description>
    <arm_group_label>3 BI 113608</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 113608</intervention_name>
    <description>conventional tablet formulation</description>
    <arm_group_label>5 BI 113608</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pantoprazole 40 mg STADA</intervention_name>
    <description>film-coated tablet</description>
    <arm_group_label>4 BI 113608</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 113608</intervention_name>
    <description>conventional tablet formulation</description>
    <arm_group_label>4 BI 113608</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        1. healthy male subjects&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        1. Any relevant deviation from healthy conditions&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1314.3.1 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Ingelheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <results_first_submitted>November 23, 2016</results_first_submitted>
  <results_first_submitted_qc>November 23, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 20, 2017</results_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</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>Pantoprazole</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>An open label, randomised, single dose, 3-way cross-over study to investigate relative bioavailability and food effect on different formulations of Boehringer-Ingelheim (BI) -113608 in healthy male subjects, followed by fixed sequence periods investigating influence of pantoprazole coadministration and food effect on pharmacokinetics of BI-113608.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>A - C - B - D - E</title>
          <description>Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.</description>
        </group>
        <group group_id="P2">
          <title>B - A - C - D - E</title>
          <description>Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.</description>
        </group>
        <group group_id="P3">
          <title>C - B - A - D - E</title>
          <description>Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
              </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="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated Set (TS): All subjects those who received at least 1 dose of study drug were included in the in the treated set.</population>
      <group_list>
        <group group_id="B1">
          <title>A - C - B - D - E</title>
          <description>Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.</description>
        </group>
        <group group_id="B2">
          <title>B - A - C - D - E</title>
          <description>Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.</description>
        </group>
        <group group_id="B3">
          <title>C - B - A - D - E</title>
          <description>Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.</description>
        </group>
        <group group_id="B4">
          <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="5"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="5"/>
            <count group_id="B4" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.4" spread="8.9"/>
                    <measurement group_id="B2" value="40.8" spread="8.6"/>
                    <measurement group_id="B3" value="41.8" spread="7.9"/>
                    <measurement group_id="B4" value="40.7" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)</title>
        <description>Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).</description>
        <time_frame>PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.</time_frame>
        <population>Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.</population>
        <group_list>
          <group group_id="O1">
            <title>A : BI-113608</title>
            <description>Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>B : BI-113608</title>
            <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.</description>
          </group>
          <group group_id="O3">
            <title>C : BI-113608</title>
            <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.</description>
          </group>
          <group group_id="O4">
            <title>D : BI-113608</title>
            <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.</description>
          </group>
          <group group_id="O5">
            <title>E : BI-113608</title>
            <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)</title>
          <description>Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).</description>
          <population>Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.</population>
          <units>nanomol (nmol)* hours (h) / Litre (L)</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="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="936" spread="27.4"/>
                    <measurement group_id="O2" value="924" spread="31.2"/>
                    <measurement group_id="O3" value="648" spread="39.3"/>
                    <measurement group_id="O4" value="900" spread="32.7"/>
                    <measurement group_id="O5" value="759" spread="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>B : BI-113608 vs. A : BI-113608 - Comparison with oral solution</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.0000</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>98.68</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>10.0</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>92.501</ci_lower_limit>
            <ci_upper_limit>105.272</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>C : BI-113608 vs. B : BI-113608 - Food effect</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.9644</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>70.16</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>18.3</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>62.331</ci_lower_limit>
            <ci_upper_limit>78.962</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>E : BI-113608 vs. B : BI-113608 - Food effect</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.2835</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>83.36</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>18.8</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>73.648</ci_lower_limit>
            <ci_upper_limit>94.346</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>E : BI-113608 vs. C : BI-113608 - Food effect</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.1599</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>117.18</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>16.7</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>104.923</ci_lower_limit>
            <ci_upper_limit>130.867</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>D : BI-113608 vs. B : BI-113608 - Pantoprazole effect</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.0020</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>97.40</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>15.8</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>88.072</ci_lower_limit>
            <ci_upper_limit>107.719</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)</title>
        <description>Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).</description>
        <time_frame>PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.</time_frame>
        <population>Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.</population>
        <group_list>
          <group group_id="O1">
            <title>A : BI-113608</title>
            <description>Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>B : BI-113608</title>
            <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.</description>
          </group>
          <group group_id="O3">
            <title>C : BI-113608</title>
            <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.</description>
          </group>
          <group group_id="O4">
            <title>D : BI-113608</title>
            <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.</description>
          </group>
          <group group_id="O5">
            <title>E : BI-113608</title>
            <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)</title>
          <description>Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).</description>
          <population>Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.</population>
          <units>nmol/L</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="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="271" spread="44.6"/>
                    <measurement group_id="O2" value="242" spread="47.5"/>
                    <measurement group_id="O3" value="132" spread="77.8"/>
                    <measurement group_id="O4" value="196" spread="50.0"/>
                    <measurement group_id="O5" value="227" spread="53.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>B : BI-113608 vs. A : BI-113608 - Comparison with oral solution</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.1261</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>89.26</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>25.3</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>75.893</ci_lower_limit>
            <ci_upper_limit>104.973</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>C : BI-113608 vs. B : BI-113608 - Food effect</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.9808</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>54.57</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>47.4</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>40.711</ci_lower_limit>
            <ci_upper_limit>73.157</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>E : BI-113608 vs. B : BI-113608 - Food effect</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.1449</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>94.88</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>43.2</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>72.175</ci_lower_limit>
            <ci_upper_limit>124.731</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>E : BI-113608 vs. C : BI-113608 - Food effect</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.9463</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>169.46</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>49.7</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>124.093</ci_lower_limit>
            <ci_upper_limit>231.419</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>D : BI-113608 vs. B : BI-113608 - Pantoprazole effect</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.4564</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>81.06</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>33.3</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>65.811</ci_lower_limit>
            <ci_upper_limit>99.848</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)</title>
        <description>Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).</description>
        <time_frame>PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.</time_frame>
        <population>Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.</population>
        <group_list>
          <group group_id="O1">
            <title>A : BI-113608</title>
            <description>Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>B : BI-113608</title>
            <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.</description>
          </group>
          <group group_id="O3">
            <title>C : BI-113608</title>
            <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.</description>
          </group>
          <group group_id="O4">
            <title>D : BI-113608</title>
            <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.</description>
          </group>
          <group group_id="O5">
            <title>E : BI-113608</title>
            <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)</title>
          <description>Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).</description>
          <population>Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.</population>
          <units>nmol*h/L</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="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="938" spread="27.4"/>
                    <measurement group_id="O2" value="926" spread="31.2"/>
                    <measurement group_id="O3" value="650" spread="39.3"/>
                    <measurement group_id="O4" value="902" spread="32.7"/>
                    <measurement group_id="O5" value="761" spread="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>B : BI-113608 vs. A : BI-113608 - Comparison with oral solution</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.0000</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>98.66</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>9.9</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>92.500</ci_lower_limit>
            <ci_upper_limit>105.225</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>C : BI-113608 vs. B : BI-113608 - Food effect</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.9635</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>70.24</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>18.3</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>62.430</ci_lower_limit>
            <ci_upper_limit>79.038</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>E : BI-113608 vs. B : BI-113608 - Food effect</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.2771</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>83.46</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>18.7</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>73.774</ci_lower_limit>
            <ci_upper_limit>94.412</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>E : BI-113608 vs. C : BI-113608 - Food effect</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.1584</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>117.16</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>16.6</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>104.958</ci_lower_limit>
            <ci_upper_limit>130.787</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>D : BI-113608 vs. B : BI-113608 - Pantoprazole effect</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%</non_inferiority_desc>
            <p_value>0.0020</p_value>
            <method>ANOVA</method>
            <method_desc>Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.</method_desc>
            <param_type>Ratio of Geometric means (%)</param_type>
            <param_value>97.41</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>15.8</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>88.066</ci_lower_limit>
            <ci_upper_limit>107.741</ci_upper_limit>
            <estimate_desc>Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first drug administration until 14 days after the last drug administration, up to 42 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>A : BI-113608</title>
          <description>Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.</description>
        </group>
        <group group_id="E2">
          <title>B : BI-113608</title>
          <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.</description>
        </group>
        <group group_id="E3">
          <title>C : BI-113608</title>
          <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.</description>
        </group>
        <group group_id="E4">
          <title>Pantoprazole 40mg</title>
          <description>Participants received single dose of Pantoprazole 40mg alone twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.</description>
        </group>
        <group group_id="E5">
          <title>D : BI-113608</title>
          <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.</description>
        </group>
        <group group_id="E6">
          <title>E : BI-113608</title>
          <description>Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" 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 15.1</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="6" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" 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="5" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01703858
org study id: 1314.3
secondary id: 2012-002537-11
nct id: NCT01703858
lead sponsor: 
The objective of the trial is to investigate the relative bioavailability, influence of
      pantoprazole coadministration and food effect of different oral formulations of BI 113608 in
      healthy male subjects
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.
description: Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
measure: Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)
time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.
description: Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).
measure: Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.
description: Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).
arm group label: 1 BI 113608
arm group type: Active Comparator
description: powder in the bottle for oral solution, oral administration with 240 mL water
arm group label: 2 BI 113608
arm group type: Experimental
description: conventional tablet formulation
arm group label: 3 BI 113608
arm group type: Experimental
description: conventional tablet formulation, fed
arm group label: 4 BI 113608
arm group type: Experimental
description: conventional tablet after pantoprazole administration
arm group label: 5 BI 113608
arm group type: Experimental
description: conventional tablet formulation, fasted, 0:30 min before fat breakfast
intervention type: Drug
intervention name: BI 113608 PIB
description: powder for oral solution
arm group label: 1 BI 113608
intervention type: Drug
intervention name: BI 113608
description: conventional tablet formulation
arm group label: 2 BI 113608
intervention type: Drug
intervention name: BI 113608
description: conventional tablet formulation
arm group label: 3 BI 113608
intervention type: Drug
intervention name: BI 113608
description: conventional tablet formulation
arm group label: 5 BI 113608
intervention type: Drug
intervention name: pantoprazole 40 mg STADA
description: film-coated tablet
arm group label: 4 BI 113608
intervention type: Drug
intervention name: BI 113608
description: conventional tablet formulation
arm group label: 4 BI 113608
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Germany
url: http://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Pantoprazole
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 