Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females
- Registration Number
- NCT02211911
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bisacodyl Bisacodyl - Sodium picosulfate Sodium picosulfate -
- Primary Outcome Measures
Name Time Method λz (terminal rate constant in plasma) up to 8 days 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) up to 8 days MRTpo (mean residence time of the analyte in the body after oral administration) up to 8 days fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) up to 8 days CL/F (apparent clearance of the analyte in plasma following extravascular administration) up to 8 days Cmax (maximum measured concentration of the analyte in plasma) up to 8 days %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation) up to 8 days t1/2 (terminal half-life of the analyte in plasma) up to 8 days tmax (time from dosing to maximum measured concentration of the analyte in plasma) up to 8 days 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) up to 8 days AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) up to 8 days Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration) up to 8 days Aet1-t2,milk (amount of analyte in milk from the time point t1 to time point t2) up to 8 days 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) up to 8 days Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) up to 8 days CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) up to 8 days fet1-t2,milk (fraction of analyte in milk from time point t1 to time point t2) up to 8 days milk to plasma ratio (AUCτ,milk / AUCτ) up to 8 days Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) up to 8 days estimated daily infant dosage up to 8 days (milk-to-plasma ratio x average maternal plasma concentration x 150 mL/kg/day)
- Secondary Outcome Measures
Name Time Method Number of patients with adverse events up to 8 days Number of patients with abnormal laboratory findings up to 8 days Number of patients with clinically significant changes in vital signs up to 8 days Number of patients with abnormal electrocardiogram findings up to 8 days Number of bowel movements up to 8 days