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

NCT02211911 | Completed Phase 1

• 1 other identifier: 122.57
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (5)

• 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

Study Arms (2)

Bisacodyl

EXPERIMENTAL

Drug: Bisacodyl

Sodium picosulfate

EXPERIMENTAL

Drug: Sodium picosulfate

Interventions

Bisacodyl DRUG

Bisacodyl

Sodium picosulfate DRUG

Sodium picosulfate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Bisacodyl; picosulfate sodium

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 8, 2014
• Study Start: February 1, 2008
• Primary Completion: May 1, 2008
• Last Updated: August 8, 2014

Record last verified: 2014-08