<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/NCT01734902</url>
  </required_header>
  <id_info>
    <org_study_id>202.846</org_study_id>
    <secondary_id>2012-003720-20</secondary_id>
    <nct_id>NCT01734902</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers</brief_title>
  <official_title>Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide, Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Study)</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 current trial is to establish the bioequivalence of 2 hyoscine&#xD;
      butylbromide dose forms following oral administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2012</start_date>
  <completion_date type="Actual">December 1, 2012</completion_date>
  <primary_completion_date type="Actual">December 1, 2012</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>Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)</measure>
    <time_frame>Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.</time_frame>
    <description>Cmax, maximum measured concentration of the hyoscine butylbromide in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)</measure>
    <time_frame>Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.</time_frame>
    <description>AUC0-tz, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )</measure>
    <time_frame>Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.</time_frame>
    <description>AUC0-∞, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>1 Hyoscine butylbromide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>drops, oral administration with 240 mL water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 Hyoscine butylbromide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sugar coated tablets, oral administration with 240 mL water</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyoscine butylbromide</intervention_name>
    <description>sugar coated tablets for oral administration</description>
    <arm_group_label>2 Hyoscine butylbromide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyoscine butylbromide</intervention_name>
    <description>drops for oral administration</description>
    <arm_group_label>1 Hyoscine butylbromide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        1. Healthy male and female subjects&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        1. Any relevant deviation from healthy conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</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>202.846.1 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>April 2019</verification_date>
  <study_first_submitted>November 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <results_first_submitted>December 20, 2018</results_first_submitted>
  <results_first_submitted_qc>April 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 23, 2019</results_first_posted>
  <last_update_submitted>April 22, 2019</last_update_submitted>
  <last_update_submitted_qc>April 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</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>Scopolamine</mesh_term>
    <mesh_term>Butylscopolammonium Bromide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Randomised, single-dose, open-label, two-way crossover trial in healthy volunteers to investigate and compare the relative bioavailability of two formulations of hyoscine butylbromide administered orally as drops (T: test treatment) or as sugar-coated Buscopan® tablets(R: reference treatment).</recruitment_details>
      <pre_assignment_details>All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be randomized to trial treatment if any one of the specific entry criteria were not met.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Buscopan® Tablet (R)/Hyoscine Butylbromide Drops (T)</title>
          <description>Participants administered orally in the morning on Day 1 of period 1 with single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan®, followed by 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.</description>
        </group>
        <group group_id="P2">
          <title>Hyoscine Butylbromide Drops (T)/Buscopan® Tablet (R)</title>
          <description>Participants administered orally in the morning on Day 1 of period 1 with 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) orally, followed by single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other than listed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated Set (TS) :The TS includes all subjects entered in the trial and treated with at least one dose of study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Buscopan® Tablet (R)/Hyoscine Butylbromide Drops (T)</title>
          <description>Participants administered orally in the morning on Day 1 of period 1 with single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan®, followed by 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.</description>
        </group>
        <group group_id="B2">
          <title>Hyoscine Butylbromide Drops (T)/Buscopan® Tablet (R)</title>
          <description>Participants administered orally in the morning on Day 1 of period 1 with 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) orally, followed by single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="30"/>
          </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="38.1" spread="8.0"/>
                    <measurement group_id="B2" value="37.8" spread="7.5"/>
                    <measurement group_id="B3" value="37.9" spread="7.7"/>
                  </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="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>Ethnicity was not captured in this trial.</description>
          <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_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="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </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_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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)</title>
        <description>Cmax, maximum measured concentration of the hyoscine butylbromide in plasma.</description>
        <time_frame>Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.</time_frame>
        <population>Descriptive statistics is based on treated set (TS) and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)</population>
        <group_list>
          <group group_id="O1">
            <title>Hyoscine Butylbromide Drops (T)</title>
            <description>Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.</description>
          </group>
          <group group_id="O2">
            <title>Buscopan® Tablet (R)</title>
            <description>Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)</title>
          <description>Cmax, maximum measured concentration of the hyoscine butylbromide in plasma.</description>
          <population>Descriptive statistics is based on treated set (TS) and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)</population>
          <units>Picogram/millilitre [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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.3" spread="140.0"/>
                    <measurement group_id="O2" value="77.1" spread="167.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.</non_inferiority_desc>
            <param_type>Adjusted gMean ratio T/R (%)</param_type>
            <param_value>86.97</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>35.6</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>74.046</ci_lower_limit>
            <ci_upper_limit>102.151</ci_upper_limit>
            <estimate_desc>Standard error of the mean is actually intra-individual geometric coefficient variance [%]. Statistical analysis is based on PKS which includes 27 subjects.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)</title>
        <description>AUC0-tz, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point</description>
        <time_frame>Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.</time_frame>
        <population>Descriptive statistics is based on TS and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)</population>
        <group_list>
          <group group_id="O1">
            <title>Hyoscine Butylbromide Drops (T)</title>
            <description>Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.</description>
          </group>
          <group group_id="O2">
            <title>Buscopan® Tablet (R)</title>
            <description>Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)</title>
          <description>AUC0-tz, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point</description>
          <population>Descriptive statistics is based on TS and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)</population>
          <units>Picogram*hour/millilitre [pg*h/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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="564.0" spread="131.0"/>
                    <measurement group_id="O2" value="608.0" spread="139.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.</non_inferiority_desc>
            <param_type>Adjusted gMean ratio T/R (%)</param_type>
            <param_value>89.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>31.2</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>77.26</ci_lower_limit>
            <ci_upper_limit>102.62</ci_upper_limit>
            <estimate_desc>Standard error of the mean is actually intra-individual geometric coefficient variance [%]. Statistical analysis is based on PKS which includes 27 subjects.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )</title>
        <description>AUC0-∞, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity</description>
        <time_frame>Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.</time_frame>
        <population>Descriptive statistics is based on TS and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)</population>
        <group_list>
          <group group_id="O1">
            <title>Hyoscine Butylbromide Drops (T)</title>
            <description>Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.</description>
          </group>
          <group group_id="O2">
            <title>Buscopan® Tablet (R)</title>
            <description>Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )</title>
          <description>AUC0-∞, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity</description>
          <population>Descriptive statistics is based on TS and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)</population>
          <units>Picogram*hour/millilitre [pg*h/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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="623.0" spread="122.0"/>
                    <measurement group_id="O2" value="668.0" spread="125.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.</non_inferiority_desc>
            <param_type>Adjusted gMean ratio T/R [%]</param_type>
            <param_value>90.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>29.3</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>78.78</ci_lower_limit>
            <ci_upper_limit>102.88</ci_upper_limit>
            <estimate_desc>Standard error of the mean is actually intra-individual geometric coefficient variance [%]. Statistical analysis is based on PKS which includes 27 subjects.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first dose of trial medication until 7 days after the end of treatment period, upto 9 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Hyoscine Butylbromide Drops (T)</title>
          <description>Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.</description>
        </group>
        <group group_id="E2">
          <title>Buscopan® Tablet (R)</title>
          <description>Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </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/NCT01734902
org study id: 202.846
secondary id: 2012-003720-20
nct id: NCT01734902
lead sponsor: 
The objective of the current trial is to establish the bioequivalence of 2 hyoscine
      butylbromide dose forms following oral administration.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)
time frame: Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.
description: Cmax, maximum measured concentration of the hyoscine butylbromide in plasma.
measure: Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
time frame: Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.
description: AUC0-tz, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point
measure: Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )
time frame: Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.
description: AUC0-∞, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity
arm group label: 1 Hyoscine butylbromide
arm group type: Experimental
description: drops, oral administration with 240 mL water
arm group label: 2 Hyoscine butylbromide
arm group type: Experimental
description: sugar coated tablets, oral administration with 240 mL water
intervention type: Drug
intervention name: Hyoscine butylbromide
description: sugar coated tablets for oral administration
arm group label: 2 Hyoscine butylbromide
intervention type: Drug
intervention name: Hyoscine butylbromide
description: drops for oral administration
arm group label: 1 Hyoscine butylbromide
criteria: 
gender: All
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: Scopolamine
mesh term: Butylscopolammonium Bromide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 