EUCTR2012-000577-22-NL进行中(未招募)1 期
Palatability testing of a new paediatric formulation of valacyclovir for the prophylaxis and treatment of VZV and HSV infections in children – VALID 0 - VALID-0
Radboud University Nijmegen Medical Centre0 个研究点目标入组 64 人开始时间: 2013年1月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject is at least 4 years of age.
- •2. Subject weighs at least 15 kg.
- •3. Subject is capable of performing the taste assessment, according to the investigator’s judgement.
- •4. The child is willing to participate in the taste assessment.
- •5. Signed informed consent by the legal guardian for participation of the child and if the parent also wants to participate: signed informed consent for their own participation, prior to start of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 35
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- •2. Presence of any condition that influences taste sensation (such as upper respiratory infection, febrile illness within 3 days before the first dose, mucositis or use of medication that influences taste perception, as described in the label information)
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