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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Bisacodyl; Picosulfate sodium

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