A Pharmacodynamic and Safety Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Healthy Volunteers
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The changes of aerobic bacterial colonization in oropharyngeal
研究概览
简要总结
To compare pharmacodynamics among the different concentrations of BCS and NS.
详细描述
2 times mouthwash in the morning and at night. To collect bacterium samples to assess the pharmacodynamics among the different concentrations of BCS and NS: observe the changes of aerobic bacterial colonization in oropharyngeal over time during 24 hours, and assess the improvement of oral healthy status and the subjective feelings after 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy volunteers, males or females.
- •Females with U-HCG negative.
- •Signed ICFs, and could conduct this study with investigators.
排除标准
- •History of mouthwash allergies, allergic rhinitis or dermatitis.
- •Volunteers with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer.
- •Volunteers with removable denture.
- •Had received special oral clean.
研究组 & 干预措施
low concentration Benzalkonium Chloride
To use low concentration Benzalkonium Chloride Solution to gargle
干预措施: Benzalkonium Chloride Solution (Drug)
high concentration Benzalkonium Chloride
To use high concentration Benzalkonium Chloride Solution to gargle
干预措施: Benzalkonium Chloride Solution (Drug)
Normal Saline
To use Normal Saline to gargle
干预措施: Benzalkonium Chloride Solution (Drug)
结局指标
主要结局
The changes of aerobic bacterial colonization in oropharyngeal
时间窗: 24 hours
To collect the throat swab samples and supragingival plaque samples before and post administration, respectively, a total of 11 time points.
次要结局
- The improvement of oral healthy status(24 hours)
- The volunteers' feelings(24 hours)