NCT00754091已完成1 期
Retention of an Orally Administered Investigational Device in the Oropharynx of Healthy Human Male Volunteers
Procter and Gamble1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2008年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area under the curve for the percent of the mucoadhesive liquid retained in the oropharynx
研究概览
简要总结
Single usage, open label study in 16 adult healthy males. Eligible subjects will receive a single usage of the investigational device. Retention of the radiolabeled device will be monitored using gamma scintigraphy.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Refrain from nasal, throat, or lung inhalants and exercise for 24 hour prior to the test
- •Are able to tolerate the procedure and
- •Be generally healthy
排除标准
- •Have history of allergy or hypersensitivity to the study ingredients
- •Major diseases
- •Taking medication regularly
- •Radiation exposure recently
研究组 & 干预措施
1
Experimental
干预措施: Polymer based lubricating liquid (Device)
结局指标
主要结局
Area under the curve for the percent of the mucoadhesive liquid retained in the oropharynx
时间窗: one hour
次要结局
未报告次要终点
研究者
研究点 (1)
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