jRCT2031240632进行中（未招募）不适用
Clinical Pharmacology Study of NS-025 in Healthy male subjects (Phase I Study) (Drug-Drug Interaction Study with triazolam) (NS025-P1-02)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 45age old not（—）
- 性别
- Male
入选标准
- •Provided written informed consent
- •Japanese male subjects
- •Body mass index (BMI) >=18.5 and <25.0 kg/m2 at the time of screening tests and hospitalization
排除标准
- •Subjects with a history of surgery which may have an impact on drug absorption
- •Subjects with a history of allergy or hypersensitivity to drugs or foods
- •Subjects who collected 200 mL or more of whole blood or component blood within 2 weeks before administration of the study drug
- •Subjects who have received other investigational products within 16 weeks (112 days) prior to the first investigational product administration
结局指标
主要结局
-
Plasma concentrations of NS-025 Plasma concentrations and PK parameters of Triazolam
次要结局
未报告次要终点
研究者
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