Randomized, single blind, cross-over study to evaluate the palatability of new orally disintegrating tablets of PZQ and L-PZQ versus current PZQ tablets in African children age 6-11 years

Merck KGaA0 个研究点目标入组 48 人开始时间: 2014年12月3日最近更新: 2023年5月29日

适应症

试验速览

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•1.Children male or female aged 6-11 years (inclusive)
•2.Parents or guardians gave written informed consent prior to any trial related procedure and child gave assent
•3.Able to communicate well with the Investigator, understanding the protocol requirements and restrictions, and willing to comply with the requirements of the entire trial
•4.Subjects should be able to hold 2 milliliter (mL) of any appropriate juice in their mouth for 10 seconds without swallowing it and to keep a candy in the mouth for 20 seconds without swallowing it
•5.Children who are able to properly assess and differentiate flavours of different soft drinks
•6.Children who are able to use a hedonic scale (children will be trained before the study)

•1.Unlikely to comply with the protocol requirements, instructions and trial-related restrictions, example: uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial
•2.Children with any condition or dietary habit known to interfere with the sense of smell and taste, ingestion of any medication (except paracetamol)
•3.Children with significant illness in the previous 2 weeks
•4.Any surgical or medical condition, or any significant disease that in the opinion of the investigator, constitutes a risk or a contraindication for the participation of the subject in the study that could interfere with the study objectives, conduct or evaluation
•5.Children who have participated in any clinical investigation within the previous 4 weeks

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