NCT03423771已完成1 期
An Exploratory Phase I/II Study on Safety, Pharmacokinetics and Efficacy of NPF-08 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Effective rate of overall intestinal cleaning effect (after washing of the observed region) by the Endoscopic Image Evaluation Committee (EIEC)
研究概览
简要总结
Japanese male healthy volunteers will receive NPF-08. The efficacy of NPF-08 will be assessed by intestinal cleaning degree. The safety of NPF-08 will be evaluated based on adverse events and adverse drug reactions observed from the date of administration to 7 days after administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese healthy male volunteers (20 to 64 years old)
- •BMI（Body Mass Index）should be within a range of 17.6 and 26.
- •Subjects who agreed not to smoke or drink during hospital stay.
- •Subjects who do not excessively consume alcohol and those who do not excessively smoke
- •Subjects who are not judged as abnormal during the screening period in the physical examinations including 12-lead ECG, clinical symptoms, clinical examination, immunological examination (hepatitis B examination, hepatitis C examination, AIDS examination, syphilis examination).
- •Subjects who are not judged as abnormal during the before administration in blood electrolyte.
- •Subjects who have no clinical abnormalities and are judged to be eligible to the study by the investigator.
排除标准
- •Subjects who had previous significant gastrointestinal surgeries.
- •Subjects with a history of 12-lead ECG abnormality.
- •Subjects who have constipation（less than 2 bowel movement per week）
- •Subjects who have addictive of diarrhea
- •Subjects who have history of shock or hypersensitivity to sulfates (sodium sulfate, potassium sulfate, magnesium sulfate, etc.).
- •Subjects who have history of drug allergy.
- •Subjects who donated 200 mL or 400 mL of whole blood 4 weeks or 12 weeks respectively prior to the administration of investigational drug, or who donated blood component last 2 weeks.
- •Subjects who have participated in an investigational study within 4 months before signing the consent.
- •Subjects who is participating in the other investigational study
- •Subjects who received NPF-08 in the past
- •Subjects who are judged by the investigator as not adequate to participate the study.
研究组 & 干预措施
NPF-08 Medium dose （2-day split dose）
Experimental
干预措施: NPF-08 (Drug)
NPF-08 High dose （2-day split dose）
Experimental
干预措施: NPF-08 (Drug)
NPF-08 Medium dose （1-day treatment）
Experimental
干预措施: NPF-08 (Drug)
NPF-08 High dose （1-day treatment）
Experimental
干预措施: NPF-08 (Drug)
NPF-08 Low～High dose （1-day treatment）
Experimental
干预措施: NPF-08 (Drug)
NPF-08 Medium～High dose （2-day split dose）
Experimental
干预措施: NPF-08 (Drug)
NPF-08 Low dose （1-day treatment）
Experimental
干预措施: NPF-08 (Drug)
结局指标
主要结局
Effective rate of overall intestinal cleaning effect (after washing of the observed region) by the Endoscopic Image Evaluation Committee (EIEC)
时间窗: 1day
次要结局
- Time for completion of the bowel cleaning(1day or 2day)
- Total dose of the investigational drug(1day)
- Acceptability by subjects(up to 6hr)
- Coincidence rate of intestinal cleansing degree (before/after washing site of observation) between by EIEC members(1day)
- Coincidence rate between the intestinal cleansing degrees evaluated by EIEC and the endoscope operators (before/after the observed site)(1day)
- Effective rate of overall intestinal cleaning effect (before washing of observed site) by EIEC(1day)
- Cleaning effect by intestinal site (before/after washing of observed site)(1day)
- Degree of bubbles by intestinal site(1day)
研究者
研究点 (1)
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