<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/NCT02261077</url>
  </required_header>
  <id_info>
    <org_study_id>202.833</org_study_id>
    <nct_id>NCT02261077</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics, Safety and Tolerability of Rising Doses of Buscopan® in Healthy Male Volunteers</brief_title>
  <official_title>A Randomised, Double-blind, Placebo-controlled Study to Assess Pharmacokinetics, Safety and Tolerability of Single Rising Oral Doses (20 mg, 60 mg, 100 mg, 200 mg and 400 mg) and Multiple Rising Oral Doses (3 x 20 mg, 3 x 60 mg and 3 x 100 mg Per Day) of Buscopan® in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to investigate pharmacokinetics, safety and tolerability of Buscopan® after single&#xD;
      rising dose and after multiple rising doses&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2007</start_date>
  <primary_completion_date type="Actual">July 2007</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum measured concentration of analyte in plasma (Cmax)</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)</measure>
    <time_frame>up to 80 hours after last drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to maximum measured concentration (tmax)</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose (AUCτ,1)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant in plasma (λz)</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of the analyte in plasma (t1/2)</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of the analyte in the body (MRTpo)</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total/apparent clearance in plasma after extravascular administration (CL/F)</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)</measure>
    <time_frame>up to 80 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of analyte eliminated in urine from time point t1 to time point t2 (fet1-t2)</measure>
    <time_frame>up to 80 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)</measure>
    <time_frame>up to 80 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average concentration of the analyte in plasma at steady-state (Cavg)</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)</measure>
    <time_frame>predose on days 1-4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linearity index (LI)</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio (RA) based on Cmax (RA,Cmax,N)</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RA,AUC,N based on AUC0-τ</measure>
    <time_frame>up to 104 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically relevant findings in vital sign parameters (blood pressure (BP), pulse rate (PR))</measure>
    <time_frame>up to 14 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically relevant findings in 12-lead electrocardiogram</measure>
    <time_frame>up to 14 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 14 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with abnormal findings in physical examination</measure>
    <time_frame>up to 14 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of adverse events</measure>
    <time_frame>up to 47 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability assessed by investigator on a 4-point scale</measure>
    <time_frame>within 14 days after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Buscopan, single rising doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Buscopan, multiple rising doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyoscine butylbromide</intervention_name>
    <arm_group_label>Buscopan, multiple rising doses</arm_group_label>
    <arm_group_label>Buscopan, single rising doses</arm_group_label>
    <other_name>Buscopan®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males based upon a complete medical history, including the physical&#xD;
             examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests. There is no&#xD;
             finding deviating from normal and of clinical relevance. There is no evidence of a&#xD;
             clinically relevant concomitant disease.&#xD;
&#xD;
          2. Age ≥21 and age ≤50 years&#xD;
&#xD;
          3. BMI ≥18.5 and BMI &lt;30 kg/m2 (Body Mass Index)&#xD;
&#xD;
          4. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any finding of the medical examination (including BP, PR and ECG) deviating from&#xD;
             normal and of clinical relevance&#xD;
&#xD;
          2. Evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          5. History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          6. Chronic or relevant acute infections&#xD;
&#xD;
          7. History of relevant allergy/hypersensitivity (including allergy to drug or its&#xD;
             excipients) as judged clinically relevant by the investigator&#xD;
&#xD;
          8. Intake of drugs with a long half-life (&gt; 24 hours) within at least one month or less&#xD;
             than 10 half-lives of the respective drug prior to randomization&#xD;
&#xD;
          9. Use of drugs which might reasonably influence the results of the trial based on the&#xD;
             knowledge at the time of protocol preparation within 10 days prior to enrolment in the&#xD;
             study or during the study&#xD;
&#xD;
         10. Participation in another trial with an investigational drug within two months prior to&#xD;
             randomization&#xD;
&#xD;
         11. Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
         12. Inability to refrain from smoking on trial days as judged by the investigator&#xD;
&#xD;
         13. Alcohol abuse (more than 40 g/day for males)&#xD;
&#xD;
         14. Drug abuse&#xD;
&#xD;
         15. Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
         16. Excessive physical activities within one week prior to administration or during the&#xD;
             trial&#xD;
&#xD;
         17. Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
         18. Inability to comply with dietary regimen of trial site&#xD;
&#xD;
         19. Hypersensitivity to hyoscine butylbromide and/or related drugs of these classes&#xD;
&#xD;
         20. History of megacolon&#xD;
&#xD;
         21. History of prostatic hyperplasia&#xD;
&#xD;
         22. History of mechanical stenosis of the gastrointestinal (e.g. after surgery of the&#xD;
             gastrointestinal tract)&#xD;
&#xD;
         23. History of narrow-angle glaucoma&#xD;
&#xD;
         24. History of tachycardic arrhythmias&#xD;
&#xD;
         25. History of myasthenia gravis&#xD;
&#xD;
         26. Bladder-neck obstruction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2014</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02261077
org study id: 202.833
nct id: NCT02261077
lead sponsor: 
Study to investigate pharmacokinetics, safety and tolerability of Buscopan® after single
      rising dose and after multiple rising doses
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Maximum measured concentration of analyte in plasma (Cmax)
time frame: up to 104 hours after last drug administration
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
time frame: up to 104 hours after last drug administration
measure: Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
time frame: up to 80 hours after last drug administration
measure: Time from dosing to maximum measured concentration (tmax)
time frame: up to 104 hours after last drug administration
measure: Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose (AUCτ,1)
time frame: up to 32 hours after drug administration
measure: Terminal rate constant in plasma (λz)
time frame: up to 104 hours after last drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
time frame: up to 104 hours after last drug administration
measure: Mean residence time of the analyte in the body (MRTpo)
time frame: up to 104 hours after last drug administration
measure: Total/apparent clearance in plasma after extravascular administration (CL/F)
time frame: up to 104 hours after last drug administration
measure: Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
time frame: up to 104 hours after last drug administration
measure: Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
time frame: up to 80 hours after last drug administration
measure: Fraction of analyte eliminated in urine from time point t1 to time point t2 (fet1-t2)
time frame: up to 80 hours after last drug administration
measure: Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)
time frame: up to 80 hours after last drug administration
measure: Average concentration of the analyte in plasma at steady-state (Cavg)
time frame: up to 104 hours after last drug administration
measure: Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
time frame: up to 104 hours after last drug administration
measure: Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
time frame: predose on days 1-4
measure: Linearity index (LI)
time frame: up to 104 hours after last drug administration
measure: Accumulation ratio (RA) based on Cmax (RA,Cmax,N)
time frame: up to 104 hours after last drug administration
measure: RA,AUC,N based on AUC0-τ
time frame: up to 104 hours after last drug administration
measure: Number of subjects with clinically relevant findings in vital sign parameters (blood pressure (BP), pulse rate (PR))
time frame: up to 14 days after last drug administration
measure: Number of subjects with clinically relevant findings in 12-lead electrocardiogram
time frame: up to 14 days after last drug administration
measure: Number of subjects with abnormal changes in laboratory parameters
time frame: up to 14 days after last drug administration
measure: Number of subjects with abnormal findings in physical examination
time frame: up to 14 days after last drug administration
measure: Occurrence of adverse events
time frame: up to 47 days
measure: Tolerability assessed by investigator on a 4-point scale
time frame: within 14 days after last drug administration
arm group label: Buscopan, single rising doses
arm group type: Experimental
arm group label: Buscopan, multiple rising doses
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Hyoscine butylbromide
arm group label: Buscopan, multiple rising doses
arm group label: Buscopan, single rising doses
other name: Buscopan®
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Scopolamine
mesh term: Butylscopolammonium Bromide