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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Bisacodyl

Drug: Sodium picosulfate

Study type

Interventional

Funder types

Industry

Identifiers

NCT02211911

122.57

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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