DRKS00033547已完成Unknown
In vivo evaluation of hard gelatin and hypromellose capsule disintegration in fasted state after intake with different fluids by salivary caffeine method
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie0 个研究点目标入组 12 人开始时间: 2024年8月2日最近更新:
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
- •Body Mass Index (BMI) between 18.0 and 29.99 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 enrollment, or within 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations
- •known allergic reactions or food intolerance to the capsules or fluids ingredients
- •problems to swallow large 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 (e.g. vegan)
- •eating disorders e.g. anorexia, bulimia
- •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
- •less than 2 weeks after last acute disease
- •less than 1 week after last blood donation
研究者
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