NCT05802628已完成4 期
A Single-arm, Open-label Study to Explore the Salivary Concentration of Cetylpyridinium Chloride Buccal Tablets After Single-dose Administration in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Salivary plasma drug concentration
研究概览
简要总结
The study is a single-arm, open-label study to explore the salivary concentration of Cetylpyridinium Chloride Buccal Tablets after single-dose administration in Healthy Subjects
详细描述
Primary Objective: To observe the concentration of the investigational product in the saliva of healthy subjects.
Secondary purpose: To observe the safety of the investigational product in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have fully understand the objective, character, methods and potential adverse reactions of the trial, voluntarily participate in the study, and sign the informed consent form before enrolled into the study.
- •Healthy subjects aged 18-45 (both inclusive) with an appropriate ratio of male to female.
- •Subjects who had no parenthood plan from the signing of the informed consent form to one month after completing study, and agreed to take effective and appropriate contraceptive measures voluntarily by themselves and their partners during this period.
- •Subjects those who be able to communicate well with investigators, and be able to understand and comply with the requirements of this study.
排除标准
- •Allergic to any ingredients of this product or excipients (sucrose, Hypromellose, Carbomer 934P, Tartrazine aluminium lake, menthol,Magnesium octadecanoate, Povidone K 30)
- •Pregnant or breastfeeding women
- •Participants with abnormal salivary secretion, such as patients with xerostomia and diabetic dry mouth
- •Usage of oral stimulants, salivary gland stimulants, other treatments or saliva substitute treatment that may affect salivary gland secretion within 7 days before screening
- •Those who cannot tolerate venipuncture or have a history of haemorrhage or needle fainting
- •Those who on special diet, who cannot comply with the standard diet of the study center, who have difficulty swallowing, who are lactose intolerant, or who have galactosemia or glucose/galactose absorption disorders
- •Those who indicated as abnormal with clinical significance in screening laboratory examination, physical examination, vital signs or electrocardiogram inspection based on judgement of clinical study doctor.
- •The subjects may not be able to complete the study following protocol due to other reasons or investigators judge that they are not suitable participants.
研究组 & 干预措施
Investigational group
Experimental
干预措施: Cetylpyridinium Chloride Buccal Tablets (Drug)
结局指标
主要结局
Salivary plasma drug concentration
时间窗: 15 minutes, 0.5 hour, 1 hour, 1.5 hours, 2 hours after dosing
Detecting the salivary drug concentration after dosing
次要结局
- Total salivary volume(The total salivary volume at the same time point on Day 0 and Day 1)
研究者
Yi Fang
Professor of Pharmacy
Peking University People's Hospital
研究点 (1)
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