Phase I Clinical Study on Oral Nemonoxacin Malate Capsules
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.
详细描述
Single dose study: evaluate safety and tolerability of oral nemonoxacin 125 mg, 250mg, 500mg, 750mg, and 1000mg.
Multiple dose study: evaluate PK profile of oral doses of 500mg or 750mg nemo after consecutive 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 males and females, aged between 18 and 45 during screening
- •Male volunteers who are capable of taking double-barrier contraception measures during the test (spermicide gel plus condom, for instance) until the end of the clinical study and do not cause their spouses to conceive within three months after the last administration of the medication; if the subjects are females, they shall not become pregnant during the test and within three months after the study
- •No use of tobacco or nicotine product within 3 months prior to this study
- •BMI 19-25
- •Willing to abstain from coffee and any caffeine drink during the study
- •Voluntarily sign the informed consent
排除标准
- •History of diabetes, or cardiovascular, hepatic or renal disease
- •Active digestive disease (e.g. diarrhea)
- •Central nervous disease or psychiatric disorders
- •Had surgery or trauma within 6 months prior to this study
- •Alcohol or drug abuse
- •HIV, HBV or HCV positive
- •Used any prescribed drug (including traditional chinese medicine) within 14 days prior to the study
- •Donated 400ml of blood or plasma within 3 months prior to this study
- •Have an abnormal laboratory examination value that exceeds the normal range by 10%
- •Drug allergies
- •Have cardiac disorders or have a family history of cardiac disorders
- •Have abnormal 12-lead ECG during screening
- •Pregnant or lactating
- •Participated in any study within 3 months prior to this study
研究组 & 干预措施
Placebo
Placebo
干预措施: Nemonoxacin (Drug)
Nemonoxacin 125mg
Nemonoxacin 125mg
干预措施: Nemonoxacin (Drug)
Nemonoxacin 250mg
Nemonoxacin 250mg
干预措施: Nemonoxacin (Drug)
Nemonoxacin 500mg
Nemonoxacin 500mg
干预措施: Nemonoxacin (Drug)
Nemonoxacin 750mg
Nemonoxacin 750mg
干预措施: Nemonoxacin (Drug)
Nemonoxacin 1000mg
Nemonoxacin 1000mg
干预措施: Nemonoxacin (Drug)
结局指标
主要结局
Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers
时间窗: 7 days
Pharmacokinetic profile of single oral dose of nemonoxacin in healthy Chinese volunteers
时间窗: 7 days
Pharmacokinetic profile of repeated oral doses of nemonoxacin in healthy Chinese volunteers
时间窗: 17 days
次要结局
未报告次要终点