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

Investigation of the Pharmacokinetics of 10 mg Bisacodyl (Coated Tablets) or 10 mg Sodium Picosulfate (Drops) Administered Orally in Healthy Lactating Females

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Bisacodyl; Drug: Sodium picosulfate

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bisacodyl	Drug: Bisacodyl
Experimental: Sodium picosulfate	Drug: Sodium picosulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	(milk-to-plasma ratio x average maternal plasma concentration x 150 mL/kg/day)	up to 8 days
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 7, 2014
• First Posted (Estimate): August 8, 2014

Study Record Updates

• Last Update Posted (Estimate): August 8, 2014
• Last Update Submitted That Met QC Criteria: August 7, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl; Picosulfate sodium
• Other Study ID Numbers: 122.57