Clinical trial NCT02211911: Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-08
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: up to 8 days
measure: tmax (time from dosing to maximum measured concentration of the analyte in plasma)
timeFrame: 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)
timeFrame: 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)
timeFrame: 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)
timeFrame: up to 8 days
measure: %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)
timeFrame: up to 8 days
measure: λz (terminal rate constant in plasma)
timeFrame: up to 8 days
measure: t1/2 (terminal half-life of the analyte in plasma)
timeFrame: up to 8 days
measure: MRTpo (mean residence time of the analyte in the body after oral administration)
timeFrame: up to 8 days
measure: CL/F (apparent clearance of the analyte in plasma following extravascular administration)
timeFrame: up to 8 days
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration)
timeFrame: up to 8 days
measure: Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
timeFrame: up to 8 days
measure: fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
timeFrame: up to 8 days
measure: CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
timeFrame: up to 8 days
measure: Aet1-t2,milk (amount of analyte in milk from the time point t1 to time point t2)
timeFrame: up to 8 days
measure: fet1-t2,milk (fraction of analyte in milk from time point t1 to time point t2)
timeFrame: 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)
timeFrame: up to 8 days
measure: milk to plasma ratio (AUCτ,milk / AUCτ)
timeFrame: up to 8 days
measure: estimated daily infant dosage
timeFrame: up to 8 days
measure: Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
timeFrame: up to 8 days
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 8 days
measure: Number of patients with abnormal laboratory findings
timeFrame: up to 8 days
measure: Number of patients with abnormal electrocardiogram findings
timeFrame: up to 8 days
measure: Number of patients with clinically significant changes in vital signs
timeFrame: up to 8 days
measure: Number of bowel movements
timeFrame: up to 8 days
Other outcomes:
Locations:
Study officials:
References: