jRCT2071240058进行中（未招募）不适用
Clinical Pharmacology Study of NS-229 in Healthy female subjects (Phase I Study) (Drug-Drug Interaction Study with combined oral contraceptive)
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
- Plasma concentrations of combined oral contraceptive
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 40age old not（—）
- 性别
- Female
入选标准
- •Provided written informed consent
- •Japanese female subjects
- •Body mass index (BMI) >=18.5 and <25.0 kg/m2 at the time of screening tests and hospitalization
排除标准
- •Sublects who are pregnant, may become pregnant, or wish to become pregnant during the trial period
- •Subjects who are breastfeeding
- •Subjects who have not confirmed a regular menstrual cycle at the time of screening test
- •Subjects who are irregular bleeding
结局指标
主要结局
Plasma concentrations of combined oral contraceptive
Plasma concentrations of combined oral contraceptive
PK parameters of combined oral contraceptive
PK parameters of combined oral contraceptive
Plasma concentrations of NS-229
Plasma concentrations of NS-229
PK parameters of NS-229
PK parameters of NS-229
次要结局
未报告次要终点
研究者
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