DRKS00032457已完成Unknown
In vivo evaluation of press-coated tablets with caffeine for the determination of gastric water emptying in fasted and fed state and the influence of MEDCOAT® - kinetic press-coated tablets
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie0 个研究点目标入组 12 人开始时间: 2023年8月21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
- 12
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
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •written informed consent (Einverständniserklärung) ICF must be obtained before any assessment is performed
- •BMI: <18.0 kg/m² and < 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
- •known allergic reactions or food intolerance to the tablets or meals ingredients
- •problems to swallow large tablets/capsules
- •gastrointestinal diseases and/or pathological findings, which might interfere with gastrointestinal motility and emptying processes
- •drug or alcohol addiction
- •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, regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
- •medical 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
- •on the day of the study and for at least one week prior to it, do not take any medication that could affect the motility, function or secretion of the gastrointestinal tract, including: laxatives, antidiarrhoeal agents, prokinetic agents, antiemetics, medications with pronounced anticholinergic effects such as antidepressants or neuroleptics, opioids, antibiotics, proton pump inhibitors, antacids, H2 antihistamines, calcium antagonists, beta blockers, nitrates.
研究者
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