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

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