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Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females

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ClinicalTrials.gov Identifier: NCT02211911
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Bisacodyl Drug: Sodium picosulfate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the Pharmacokinetics of 10 mg Bisacodyl (Coated Tablets) or 10 mg Sodium Picosulfate (Drops) Administered Orally in Healthy Lactating Females
Study Start Date : February 2008
Actual Primary Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bisacodyl Drug: Bisacodyl
Experimental: Sodium picosulfate Drug: Sodium picosulfate



Primary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 8 days ]
  2. tmax (time from dosing to maximum measured concentration of the analyte in plasma) [ Time Frame: up to 8 days ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation) [ Time Frame: up to 8 days ]
  7. λz (terminal rate constant in plasma) [ Time Frame: up to 8 days ]
  8. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 8 days ]
  9. MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 8 days ]
  10. CL/F (apparent clearance of the analyte in plasma following extravascular administration) [ Time Frame: up to 8 days ]
  11. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration) [ Time Frame: up to 8 days ]
  12. 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 ]
  13. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: up to 8 days ]
  14. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: up to 8 days ]
  15. Aet1-t2,milk (amount of analyte in milk from the time point t1 to time point t2) [ Time Frame: up to 8 days ]
  16. fet1-t2,milk (fraction of analyte in milk from time point t1 to time point t2) [ Time Frame: up to 8 days ]
  17. 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 ]
  18. milk to plasma ratio (AUCτ,milk / AUCτ) [ Time Frame: up to 8 days ]
  19. estimated daily infant dosage [ Time Frame: up to 8 days ]
    (milk-to-plasma ratio x average maternal plasma concentration x 150 mL/kg/day)

  20. Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: up to 8 days ]

Secondary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: up to 8 days ]
  2. Number of patients with abnormal laboratory findings [ Time Frame: up to 8 days ]
  3. Number of patients with abnormal electrocardiogram findings [ Time Frame: up to 8 days ]
  4. Number of patients with clinically significant changes in vital signs [ Time Frame: up to 8 days ]
  5. Number of bowel movements [ Time Frame: up to 8 days ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women, age ≥18 and ≤50 years
  • Stopped with breast feeding their baby
  • Provided breast milk samples over a period of 10 days (including day -1)
  • Have been breast feeding for at least 14 days
  • Complied with the requirements of the protocol (e.g complete a diary)
  • Body Mass Index (BMI) ≤ 35 kg/m2
  • Medically acceptable method of contraception [i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive) or intrauterine device
  • Signed and dated a written informed consent prior to any study procedures study in accordance with Good Clinical practice (GCP) and the local legislation

Exclusion Criteria:

  • Findings during medical examination (including BP, pulse rate and ECG) deviating from normal and of clinical relevance
  • Evidence of clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency, myocardial infarction, other known cardiovascular disease including hypertension
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, that may interfere with the safety of the subject
  • Surgery of the gastrointestinal tract (except appendectomy) in the last 2 years
  • Metabolic disorders, neurological disorders, severe or psychiatric disorders, or any other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal surgery) that would interfere with participation in the study
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections (e.g. HIV, Hepatitis)
  • Participated in another study with an investigational product within 1 month prior to enrolment into this study or during the study
  • Eating disorder
  • Hypersensitivity to bisacodyl, sodium picosulfate or any of the inactive ingredients
  • Any concomitant medication except for paracetamol or hormonal therapy.
  • Abnormal electrolyte values at the screening visit. The electrolyte values should be within the normal ranges
  • Alcohol abuse; subjects who report regular consumption of 40g/day = 5 units/day or more alcoholic drinks per day were excluded
  • Smoker (>10 cigarettes or > 3 cigars or > 3 pipes/day)
  • Drug abuse
  • Any laboratory value outside the reference range that is of clinical relevance
  • Mastitis
  • Less than 200 ml daily (24 hours) production of breast milk on day -1
  • A positive pregnancy test at screening

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02211911     History of Changes
Other Study ID Numbers: 122.57
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Bisacodyl
Picosulfate sodium
Cathartics
Gastrointestinal Agents
Laxatives