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Randomized, open-label, single dosing, cross-over study to investigate the acceptability, swallowability and palatability of multiple coated drug-free minitablets in young children - Multiple coated drug-free minitablets in young children

Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf0 个研究点目标入组 320 人开始时间: 2022年1月7日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Children aged from 1 month to 6 years inclusive
•2. Male and female
•3. Based on medical history, physical examination, and all other appropriate diagnostic procedures they are able to swallow. Participants suffering from illness must be able to swallow the mini-tablets and to accept the study procedures. This conclusion is based on medical history, physical examination, and all other appropriate diagnostic procedures as assessed by the Principal Investigator, Principal Investigator’s deputies, or sub-investigators.
•4. Participants and participants’ parents understand and are willing, able, and likely to comply with examination procedures and restrictions.
•5. Participant and/or participant’s parents or legal guardians are capable of understanding the examination procedures, participant obligations as well as risks and benefits of participation in this study and have given written informed consent and assent where possible.

•Disease/Illness
•1. Any impairment of swallowing solids as a consequence of chronic illness (e.g. cerebral palsy), acute illness (e.g. sepsis, respiratory distress, gastroenteritis, respiratory tract infection), or oral deformation, as assessed by the Investigator.
•Intolerance
•2. Lactose-Intolerance
•Pre- and Concomitant Medication
•3. Any drug that causes nausea, fatigue, or palsy
•Intervention
•4. Children in the post-operative period who have yet to commence regular oral feeding
•5. Children, who have eaten one hour before examination and who afterwards feel sick because of the food

发起方

Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf