DRKS00032267已完成Unknown
In vivo evaluation of an enteric capsule type in fed state
Institut für Pharmazie, Biopharmazie & Pharmazeutische Technologie0 个研究点目标入组 16 人开始时间: 2023年7月12日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •18.0 kg/m² < BMI < 30 kg/m²
- •good health as evidenced by the results of the physical examination, which are judged by the responsible physician not to differ in a clinically relevant way from the normal state
排除标准
- •Current participation in any clinical study including the use of any investigational drugs at the time of enrolment, or within 5 half-lives of enrolment, whichever is longer; or longer if required by local regulations
- •weight less than 45 kg
- •any contraindications for MRI including but not limited to the following: any metal bearing implants (excluding dental retainer), cardiac pacemakers, brain aneurysm clip, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body (e.g. metal shavings), implanted insulin pump, tattoos (as determined by imager) or claustrophobia
- •known allergic reactions or food intolerances to capsule materials or labelling agents
- •gastrointestinal diseases and/or pathological findings, which might interfere with gastrointestinal motility and emptying processes
- •medication that might interfere with gastrointestinal motility
- •drug or alcohol dependence
- •smokers of 10 or more cigarettes per day
- •subjects who are on a diet which could affect gastrointestinal motility (vegetarian, vegan)
- •eating disorders e.g. anorexia, bulimia
- •heavy tea or coffee drinkers (more than 1L per day)
- •lactating and pregnant women (positive urine test)
- •subjects suspected or known not to follow instructions
- •subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
- •history of orthostatic dysregulation, fainting, or blackouts
- •less than 2 weeks after last acute disease
- •less than 1 week after last blood donation
- •therapy with transdermal patches
- •medication that might interfere with gastrointestinal motility
研究者
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