Investigation of the Pharmacokinetics of 10 mg Bisacodyl (Coated Tablets) or 10 mg Sodium Picosulfate (Drops) Administered Orally in Healthy Lactating Females
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- λz (terminal rate constant in plasma)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Less than 200 ml daily (24 hours) production of breast milk on day -1
- •A positive pregnancy test at screening
研究组 & 干预措施
Bisacodyl
干预措施: Bisacodyl (Drug)
Sodium picosulfate
干预措施: Sodium picosulfate (Drug)
结局指标
主要结局
λz (terminal rate constant in plasma)
时间窗: 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)
时间窗: up to 8 days
MRTpo (mean residence time of the analyte in the body after oral administration)
时间窗: up to 8 days
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
时间窗: up to 8 days
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: up to 8 days
%AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)
时间窗: up to 8 days
t1/2 (terminal half-life of the analyte in plasma)
时间窗: up to 8 days
CL/F (apparent clearance of the analyte in plasma following extravascular administration)
时间窗: up to 8 days
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
时间窗: 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)
时间窗: 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)
时间窗: up to 8 days
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration)
时间窗: up to 8 days
Aet1-t2,milk (amount of analyte in milk from the time point t1 to time point t2)
时间窗: 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)
时间窗: up to 8 days
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
时间窗: up to 8 days
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
时间窗: up to 8 days
fet1-t2,milk (fraction of analyte in milk from time point t1 to time point t2)
时间窗: up to 8 days
milk to plasma ratio (AUCτ,milk / AUCτ)
时间窗: up to 8 days
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
时间窗: up to 8 days
estimated daily infant dosage
时间窗: up to 8 days
(milk-to-plasma ratio x average maternal plasma concentration x 150 mL/kg/day)
次要结局
- 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 clinically significant changes in vital signs(up to 8 days)
- Number of patients with abnormal electrocardiogram findings(up to 8 days)
- Number of bowel movements(up to 8 days)