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

NCT ID: NCT02211911

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29

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 days.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bisacodyl

Group Type: EXPERIMENTAL

Bisacodyl

Intervention Type: DRUG

Sodium picosulfate

Group Type: EXPERIMENTAL

Sodium picosulfate

Intervention Type: DRUG

Interventions

Bisacodyl

Intervention Type: DRUG

Sodium picosulfate

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

122.57

Identifier Type: -

Identifier Source: org_study_id