ACTRN12623000410651已完成Unknown
Assessment of systemic pharmacokinetics of capsaicin following intranasal administration of a recognised therapeutic dose in healthy adults
Professor Peter Smith0 个研究点目标入组 26 人开始时间: 2023年4月26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
- 26
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-randomised trial
- 主要目的
- Treatment
- 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
- •Aged 18-55 years;
- •= Healthy volunteers as defined by no acute or chronic airway illness or a smoker
- •- Complete informed consent to nasal capsaicin at 2 time points (at least 2 weeks apart)
- •- Agree to the measurement of blood samples at 5 time points.
排除标准
- •- Asthma, Allergic or Non-Allergic Rhinitis, Intercurrent illness, Chronic rhinosinusitis or have a history of psychiatric disorders or is unreliable in the opinion of the investigator Have a known sensitivity to capsaicin or any ingredients in the formulation
- •- Are a smoker
- •- Have any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
- •- Are a female participant who is currently pregnant or breast-feeding.
- •- Have participated in an interventional Trial with an investigational medicinal product (IMP) or device 30 days before signing informed consent.
- •- Have used any nasal medication that may have an influence on the nasal homeostasis or nasal physiology within 1 week before the capsaicin application
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