DRKS00032726已完成Unknown
Study to investigate the influence of different coatings on the esophageal transit of tablets - MRI_EsoCoatings
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie0 个研究点目标入组 36 人开始时间: 2024年3月13日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 36
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •BMI: 18 – 30 kg/m² .
- •Signed written informed consent.
- •Good health as evidenced by the results of the inclusion anamnesis which does not differ in a clinically relevant way from the normal state and does not implicate a disease requiring long-term medication.
排除标准
- •? Patients with dysphagia
- •? Patients with swallowing difficulties in respect to solid oral dosage forms which do not allow safe and reliable study participation
- •? Any contraindications to MRI imaging including, in particular, implants containing metal (except dental retainers), pacemakers, brain aneurysm clips, brain or pacemaker leads, implanted defilibrators, artificial heart valves, cochlear implants, foreign bodies in the eye, implanted insulin pumps, large and dark tattoos, and claustrophobia
- •? Known intolerance against any of the dosage form materials
- •? Alcohol and drug dependency
- •? Concomitant medication with drugs known to affect gastrointestinal function in particular:
- •o Laxatives
- •o Antidiarrheal
- •o Prokinetics
- •o Antiemetics
- •o Medication with pronounced anticholinergic effects such as antidepressants or neuroleptics
- •o Antibiotics
- •o Proton pump inhibitors, antacids, H2-antihistaminics
- •o Calcium antagonists
- •o Beta blockers
- •? Gastrointestinal diseases and/or pathological changes that may interfere with the swallowing process
- •? History of orthostatic dysregulation or fainting (<1 year)
- •? Persons not being able to follow the instructions reliably
- •? Persons not being able to understand written or spoken instructions and indoctrinations regarding risks they are going to envisage
- •? Accommodation in an institute due to judicial order or regulatory action
- •? Participation in a clinical trial according to Arzneimittelgesetz, AMG, less than one month ago
- •? Eating disorders such as anorexia, bulimia
- •? Pregnant or breastfeeding persons
- •? Therapy with transdermal therapeutic systems
- •? Less then 7 days after full blood donation
- •? Less then 7 days after acute disease/infection
- •? Being in a state of dependence to study personnel
研究者
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