<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/NCT02211911</url>
  </required_header>
  <id_info>
    <org_study_id>122.57</org_study_id>
    <nct_id>NCT02211911</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females</brief_title>
  <official_title>Investigation of the Pharmacokinetics of 10 mg Bisacodyl (Coated Tablets) or 10 mg Sodium Picosulfate (Drops) Administered Orally in Healthy Lactating Females</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To investigate if bisacodyl (Dulcolax®) and sodium picosulfate (Laxoberal®) is excreted in&#xD;
      breast milk of healthy lactating women after an oral administration of 10 mg once daily over&#xD;
      a period of 8 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2008</start_date>
  <primary_completion_date type="Actual">May 2008</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>tmax (time from dosing to maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>%AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>MRTpo (mean residence time of the analyte in the body after oral administration)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F (apparent clearance of the analyte in plasma following extravascular administration)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Aet1-t2,milk (amount of analyte in milk from the time point t1 to time point t2)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>fet1-t2,milk (fraction of analyte in milk from time point t1 to time point t2)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCτ,milk (area under the concentration-time curve of the analyte in milk over a uniform dosing interval τ after administration of the first dose)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>milk to plasma ratio (AUCτ,milk / AUCτ)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>estimated daily infant dosage</measure>
    <time_frame>up to 8 days</time_frame>
    <description>(milk-to-plasma ratio x average maternal plasma concentration x 150 mL/kg/day)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)</measure>
    <time_frame>up to 8 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal laboratory findings</measure>
    <time_frame>up to 8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal electrocardiogram findings</measure>
    <time_frame>up to 8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs</measure>
    <time_frame>up to 8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of bowel movements</measure>
    <time_frame>up to 8 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Bisacodyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium picosulfate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bisacodyl</intervention_name>
    <arm_group_label>Bisacodyl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium picosulfate</intervention_name>
    <arm_group_label>Sodium picosulfate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women, age ≥18 and ≤50 years&#xD;
&#xD;
          -  Stopped with breast feeding their baby&#xD;
&#xD;
          -  Provided breast milk samples over a period of 10 days (including day -1)&#xD;
&#xD;
          -  Have been breast feeding for at least 14 days&#xD;
&#xD;
          -  Complied with the requirements of the protocol (e.g complete a diary)&#xD;
&#xD;
          -  Body Mass Index (BMI) ≤ 35 kg/m2&#xD;
&#xD;
          -  Medically acceptable method of contraception [i.e., double barrier method (e.g.,&#xD;
             diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable,&#xD;
             intra-vaginal, or oral contraceptive) or intrauterine device&#xD;
&#xD;
          -  Signed and dated a written informed consent prior to any study procedures study in&#xD;
             accordance with Good Clinical practice (GCP) and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Findings during medical examination (including BP, pulse rate and ECG) deviating from&#xD;
             normal and of clinical relevance&#xD;
&#xD;
          -  Evidence of clinically relevant concomitant diseases like renal insufficiency, cardiac&#xD;
             insufficiency, myocardial infarction, other known cardiovascular disease including&#xD;
             hypertension&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders, that may interfere with the safety of the subject&#xD;
&#xD;
          -  Surgery of the gastrointestinal tract (except appendectomy) in the last 2 years&#xD;
&#xD;
          -  Metabolic disorders, neurological disorders, severe or psychiatric disorders, or any&#xD;
             other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal&#xD;
             surgery) that would interfere with participation in the study&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections (e.g. HIV, Hepatitis)&#xD;
&#xD;
          -  Participated in another study with an investigational product within 1 month prior to&#xD;
             enrolment into this study or during the study&#xD;
&#xD;
          -  Eating disorder&#xD;
&#xD;
          -  Hypersensitivity to bisacodyl, sodium picosulfate or any of the inactive ingredients&#xD;
&#xD;
          -  Any concomitant medication except for paracetamol or hormonal therapy.&#xD;
&#xD;
          -  Abnormal electrolyte values at the screening visit. The electrolyte values should be&#xD;
             within the normal ranges&#xD;
&#xD;
          -  Alcohol abuse; subjects who report regular consumption of 40g/day = 5 units/day or&#xD;
             more alcoholic drinks per day were excluded&#xD;
&#xD;
          -  Smoker (&gt;10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Mastitis&#xD;
&#xD;
          -  Less than 200 ml daily (24 hours) production of breast milk on day -1&#xD;
&#xD;
          -  A positive pregnancy test at screening&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 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>August 2014</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 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>Bisacodyl</mesh_term>
    <mesh_term>Picosulfate sodium</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/NCT02211911
org study id: 122.57
nct id: NCT02211911
lead sponsor: 
To investigate if bisacodyl (Dulcolax®) and sodium picosulfate (Laxoberal®) is excreted in
      breast milk of healthy lactating women after an oral administration of 10 mg once daily over
      a period of 8 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 8 days
measure: tmax (time from dosing to maximum measured concentration of the analyte in plasma)
time frame: up to 8 days
measure: AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)
time frame: up to 8 days
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 8 days
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)
time frame: up to 8 days
measure: %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)
time frame: up to 8 days
measure: λz (terminal rate constant in plasma)
time frame: up to 8 days
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 8 days
measure: MRTpo (mean residence time of the analyte in the body after oral administration)
time frame: up to 8 days
measure: CL/F (apparent clearance of the analyte in plasma following extravascular administration)
time frame: up to 8 days
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration)
time frame: up to 8 days
measure: Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
time frame: up to 8 days
measure: fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
time frame: up to 8 days
measure: CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
time frame: up to 8 days
measure: Aet1-t2,milk (amount of analyte in milk from the time point t1 to time point t2)
time frame: up to 8 days
measure: fet1-t2,milk (fraction of analyte in milk from time point t1 to time point t2)
time frame: up to 8 days
measure: AUCτ,milk (area under the concentration-time curve of the analyte in milk over a uniform dosing interval τ after administration of the first dose)
time frame: up to 8 days
measure: milk to plasma ratio (AUCτ,milk / AUCτ)
time frame: up to 8 days
measure: estimated daily infant dosage
time frame: up to 8 days
description: (milk-to-plasma ratio x average maternal plasma concentration x 150 mL/kg/day)
measure: Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
time frame: up to 8 days
measure: Number of patients with adverse events
time frame: up to 8 days
measure: Number of patients with abnormal laboratory findings
time frame: up to 8 days
measure: Number of patients with abnormal electrocardiogram findings
time frame: up to 8 days
measure: Number of patients with clinically significant changes in vital signs
time frame: up to 8 days
measure: Number of bowel movements
time frame: up to 8 days
arm group label: Bisacodyl
arm group type: Experimental
arm group label: Sodium picosulfate
arm group type: Experimental
intervention type: Drug
intervention name: Bisacodyl
arm group label: Bisacodyl
intervention type: Drug
intervention name: Sodium picosulfate
arm group label: Sodium picosulfate
criteria: 
gender: Female
minimum age: 18 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: Bisacodyl
mesh term: Picosulfate sodium