NCT04494178终止不适用
A Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate the Effect of G-PUR® on Dietary Fumonisin Bioavailability
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2
研究概览
简要总结
This prospective, placebo-controlled, randomized, monocentric, double-blind, crossover study in healthy volunteers aims to assess the effect of a single dose of 2 g G-PUR® on bioavailability of dietary fumonisin and to evaluate safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects
- •Age 18-55 years
- •Subjects are in good clinical and mental health as established by medical history and physical examination
- •Subject understands the scope of the study and agrees to strictly adhere to the study related diet plan
- •Written informed consent
排除标准
- •Pregnancy or breastfeeding.
- •Lack of willingness or capacity to co-operate appropriately
- •Regular use of medications in the previous 2 months (except oral contraception)
- •History of malignancies within the past two years or on current anticancer treatment
- •History of gastrointestinal pathology such as clinically relevant gastritis, gastric ulcers, inflammatory bowel disease, chronic constipation
- •History of diarrhoea within the past 14 days of screening
- •History of gastrointestinal surgery with exception of appendectomy
- •History of any chronic liver disease
- •History of autoimmune disease requiring treatment within the past two months of screening
- •Known symptomatic food allergies
- •Active infection (including HIV and hepatitis B or C), or abnormalities in laboratory testing, vital signs, or physical examination
- •Hypersensitivity to aluminium and/or silicon
- •Chronic renal disease requiring dialysis
- •Alcohol, cigarette or drug abuse
- •Presence of any condition that impacts compliance with the study procedures
- •Use of any investigational or non-registered product (drug or device) within 30 days preceding the first study product administration, or planned use during the study period
- •Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor
结局指标
主要结局
The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2
时间窗: 24 hours
次要结局
- Incidence of (serious) adverse device effects(19 days)
- Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2)(24 hours)
研究者
研究点 (1)
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