DRKS00031999已完成Unknown
Application of saliva markers for the in vivo testing of dosage forms
Institut für Pharmazie - Biopharmazie & Pharmazeutische Technologie0 个研究点目标入组 12 人开始时间: 2023年8月28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
- Non-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: > 18 kg/m² and < 30 kg/m²
- •-Minimum weight: 50 kg
- •-Good health, judged by the investigator not to deviate from the norm in clinical terms
- •-Presentation of written informed consent
排除标准
- •- Disorders/diseases affecting the swallowing process (e.g. severe dysphagia with regard to food and/or solid oral dosage forms).
- •- claustrophobia
- •- Gastrointestinal disease and/or pathological changes that may interfere with gastric emptying.
- •- Known or suspected stenosis, fistulae or mechanical obstruction within the gastrointestinal tract.
- •- surgical procedures 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 a pacemaker, defibrillator or infusion pump
- •- Known allergies or intolerances to the ingredients of the standard meal
- •- Individuals who are unable to consume an appropriately sized portion of a meal in a given amount of time
- •- 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
- •- Positive pregnancy test or gravidity
- •- People who are known to be unwilling or unable to follow instructions reliably
- •- Individuals who are unable to understand written and verbal instructions and warnings regarding the study risks they face
- •- less than 14 days after acute illness
- •- systemic use of medications, especially those that affect gastrointestinal function
- •- known allergy or hypersensitivity to caffeine or foods containing caffeine
- •- Intolerance to lactose
研究者
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