Exploratory Study of Additional Use of Scopolamine Butylbromide, Glucagon or NPO-11 Following Single Dose of NPO-11 in Healthy Adult Men During Endoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- [Safety] (Evaluation by investigator or subinvestigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the additional administration of scopolamine butylbromide, glucagon or NPO-11 following a single intragastric dose of NPO-11 during endoscopy in healthy adult men. The safety will be evaluated based on adverse events and adverse drug reactions (ADRs) observed with NPO-11 + scopolamine butylbromide or glucagon, and following additional administration of NPO-11. The efficacy will be evaluated based on changes in the frequency of gastric peristalsis classification after the initial dose and the additional dose, and on the presence or absence of gastric peristalsis at each evaluation point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male volunteers who meet all the following criteria will be enrolled in the study. Subjects have to provide written informed consent for voluntary participation in the study.
- •Volunteers who are in good health as confirmed by the investigator or subinvestigator
- •Volunteers (age from 35 to less than 65 years old at the time of consent)
排除标准
- •Volunteers who meet any of the following criteria will be excluded from the study.
- •Volunteers with any clinically significant symptoms, physical findings or laboratory values at screening visit which are considered unsuitable for participation in the study in the investigator's or subinvestigator's opinion
- •Volunteers with a history of surgery in the upper gastrointestinal tract
- •Volunteers with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
- •Volunteers with a history of shock or hypersensitivity to scopolamine butylbromide, glucagon, lidocaine hydrochloride or heparin sodium
- •Volunteers who are contraindicated for administration of scopolamine butylbromide or glucagon in the investigator's or subinvestigator's opinion based on health interview
- •Volunteers who have been exposed to NPO-11
- •Volunteers who have received other investigational drugs within four months before consent or who are participating in other clinical studies
- •Volunteers otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
研究组 & 干预措施
N
干预措施: NPO-11 (Drug)
B
干预措施: NPO-11 (Drug)
G
干预措施: NPO-11 (Drug)
结局指标
主要结局
[Safety] (Evaluation by investigator or subinvestigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration
时间窗: 7 ± 3 days after administration
次要结局
- [Efficacy] (Central evaluation by independent evaluator) (1) Change in the frequency of gastric peristalsis classification (2) Presence or absence of gastric peristalsis at each evaluation point(each evaluation point)