DRKS00034434已完成Unknown
The effect of posture on gastric emptying and pharmacokinetics of solid oral dosage forms
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie0 个研究点目标入组 12 人开始时间: 2024年6月27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 55 Years（—）
- 性别
- All
入选标准
- •*Ethnic origin: Caucasian
- •*BMI: min. 18 kg/m² and max. 30 kg/m²
- •*minimum weight: 50 kg
- •*good state of health, which is assessed by the investigator as clinically
- •not deviating from the norm in clinical terms
- •*signed written informed consent
排除标准
- •- Disorders/diseases affecting the swallowing process (e.g. severe dysphagia in relation to food and/or solid oral dosage forms)
- •- claustrophobia
- •- gastrointestinal diseases and/or pathological changes that could interfere with gastric emptying
- •- known or suspected stenoses, fistulas or mechanical obstructions within the gastrointestinal tract
- •- Surgical interventions on the gastrointestinal tract within the last 12 months
- •- inflammatory bowel disease (Crohn's disease, ulcerative colitis or diverticulitis)
- •- implanted or portable electromechanical medical devices such as pacemakers, defibrillators or infusion pumps
- •- Large dark tattoos
- •- Known allergies or intolerances to the components of the standard meal or the administered vehicles (especially caffeine, lactose)
- •- Alcohol or drug addiction
- •- Smokers with a cigarette consumption of more than 10 cigarettes per day
- •- Heavy tea or coffee drinkers (more than 1 litre per day)
- •- Eating disorders such as anorexia, bulimia in the last 12 months
- •- People with dietary habits that affect gastrointestinal motility (vegetarians, vegans)
- •- Positive pregnancy test or pregnancy
- •- Persons who are known to be unwilling or unable to follow instructions reliably
- •- Persons who are unable to understand written and verbal instructions and instructions regarding the study risks they face
- •- less than 14 days after acute illness
- •- systemic intake of medications (except contrazeptives), especially those that affect the function of the gastrointestinal tract
研究者
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