Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bisacodyl
|
Drug: Bisacodyl
|
| Experimental: Sodium picosulfate
|
Drug: Sodium picosulfate
|
Outcome Measures
Primary Outcome Measures
- Cmax (maximum measured concentration of the analyte in plasma) [up to 8 days]
- tmax (time from dosing to maximum measured concentration of the analyte in plasma) [up to 8 days]
- AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose) [up to 8 days]
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [up to 8 days]
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz) [up to 8 days]
- %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation) [up to 8 days]
- λz (terminal rate constant in plasma) [up to 8 days]
- t1/2 (terminal half-life of the analyte in plasma) [up to 8 days]
- MRTpo (mean residence time of the analyte in the body after oral administration) [up to 8 days]
- CL/F (apparent clearance of the analyte in plasma following extravascular administration) [up to 8 days]
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration) [up to 8 days]
- Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) [up to 8 days]
- fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [up to 8 days]
- CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [up to 8 days]
- Aet1-t2,milk (amount of analyte in milk from the time point t1 to time point t2) [up to 8 days]
- fet1-t2,milk (fraction of analyte in milk from time point t1 to time point t2) [up to 8 days]
- AUCτ,milk (area under the concentration-time curve of the analyte in milk over a uniform dosing interval τ after administration of the first dose) [up to 8 days]
- milk to plasma ratio (AUCτ,milk / AUCτ) [up to 8 days]
- estimated daily infant dosage [up to 8 days]
(milk-to-plasma ratio x average maternal plasma concentration x 150 mL/kg/day)
- Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [up to 8 days]
Secondary Outcome Measures
- Number of patients with adverse events [up to 8 days]
- Number of patients with abnormal laboratory findings [up to 8 days]
- Number of patients with abnormal electrocardiogram findings [up to 8 days]
- Number of patients with clinically significant changes in vital signs [up to 8 days]
- Number of bowel movements [up to 8 days]
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 122.57