Status:
COMPLETED
Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
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 da...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02211911
Start Date
February 1 2008
Last Update
August 8 2014
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