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

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of the Pharmacokinetics of 10 mg Bisacodyl (Coated Tablets) or 10 mg Sodium Picosulfate (Drops) Administered Orally in Healthy Lactating Females

Conditions
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Healthy

Intervention / Treatment
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* Drug: Bisacodyl
* Drug: Sodium picosulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bisacodyl<br> | Drug: Bisacodyl<br> <br> |
| Experimental: Sodium picosulfate<br> | Drug: Sodium picosulfate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration 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 | 
| 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 | 
| %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation) |  | up to 8 days | 
| λz (terminal rate constant in plasma) |  | up to 8 days | 
| t1/2 (terminal half-life of the analyte in plasma) |  | up to 8 days | 
| MRTpo (mean residence time of the analyte in the body after oral administration) |  | up to 8 days | 
| CL/F (apparent clearance of the analyte in plasma following extravascular administration) |  | 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 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) |  | up to 8 days | 
| fet1-t2 (fraction of analyte eliminated in urine from 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 | 
| Aet1-t2,milk (amount of analyte in milk from the time point t1 to 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 | 
| 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 | 
| milk to plasma ratio (AUCτ,milk / AUCτ) |  | up to 8 days | 
| estimated daily infant dosage | (milk-to-plasma ratio x average maternal plasma concentration x 150 mL/kg/day) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 abnormal electrocardiogram findings |  | up to 8 days | 
| Number of patients with clinically significant changes in vital signs |  | up to 8 days | 
| Number of bowel movements |  | up to 8 days |