DRKS00033548已完成Unknown
Evaluation of gastric water emptying in fasted and fed state inyoung and advanced age populations with the use of a press-coated tablet containing caffeine - Saliva_AgePop_fasted&fed
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie0 个研究点目标入组 31 人开始时间: 2024年6月10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
- 31
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 one（—）
- 性别
- All
入选标准
- •Subjects eligible for inclusion in this study arm have to fulfill all of the following criteria:
- •written informed consent (Einverständniserklärung”) ICF must be btained before any assessment is performed
- •sex: male or female
- •Study arm 1 and 2:
- •age: =65 years
- •body mass index: =18 kg/m² and = 30 kg/m²
- •Study arm 3:
- •body mass index: =18 kg/m² and = 35 kg/m²
- •intake of 5 or more medications
- •Study arm 4 and 5:
- •Age: =18 years and < 65 years
排除标准
- •Study arm 1, 2, 4, 5:
- •Subjects fulfilling any of the following criteria are not eligible for inclusion in this study:
- •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
- •gastrointestinal diseases and/or pathological findings, which might interfere with gastrointestinal motility and emptying processes
- •gastrointestinal diseases and/or pathological findings, which pose a risk for intake of solid oral dosage forms (e.g. esophagus stents, esophagus varices, hiatal hernia)
- •diseases and/or pathological findings and/or respective treatments that do not allow the intake of a solid meal or solid oral dosage forms (e.g. dysphagia, diseases needing tube feeding)
- •drug or alcohol addiction
- •smokers of 10 or more cigarettes per day
- •eating disorders e.g. anorexia, bulimia
- •heavy tea or coffee drinkers (more than 1L per day)
- •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 study participation
- •cognitive impairments that disable subjects to give informed consent (e.g. Alzheimer’s disease, Dementia)
- •medical history of orthostatic dysregulation, fainting, or blackouts
- •medical history of upper gastrointestinal surgical procedure
- •chemotherapy
- •less than 2 weeks after last acute disease
- •less than 1 week after last blood donation
- •therapy with transdermal patches
- •therapy with drugs that affect the gastrointestinal motility (The use of oral contraceptives is permitted in study arms 4 and 5)
- •therapy with drugs that alter gastric pH
- •Study arm 3:
- •Subjects fulfilling any of the following criteria are not eligible for inclusion in this study:
- •weight less than 45 kg
- •known allergic reactions or food intolerance to the tablets or meals ingredients
- •gastrointestinal diseases and/or pathological findings, which pose a risk for intake of solid oral dosage forms (e.g. esophagus stents, esophagus varices, hiatal hernia)
- •diseases and/or pathological findings that do not allow the intake of a solid meal or solid oral dosage forms (e.g. dysphagia, diseases needing tube feeding)
- •drug or alcohol addiction
- •heavy tea or coffee drinkers (more than 1L per day)
- •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 study participation
- •cognitive impairments that disable subjects to give informed consent (e.g. Alzheimer’s disease, Dementia)
研究者
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