jRCT2031250069招募中不适用
Clinical pharmacokinetic study of MD-352 in healthy postmenopausal female subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 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
- Randomized Controlled Trial
- 干预模型
- Crossover Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 45age old over 至 65age old not（—）
- 性别
- Female
入选标准
- •Subjects with a BMI of at least 18.5 kg/m2 and less than 25.0 kg/m2 and a body weight of at least 45 kg and less than 65 kg at screening
- •Postmenopausal women who have been without menstruation for 12 or more months without accompanying medical reasons
排除标准
- •Subjects deemed unsuitable by the principal investigator or sub-investigator
- •Subjects with drug hypersensitivity
- •Subjects who have used drugs and supplements within 7 days prior to administration of the investigational drug
- •Subjects with a positive result in urine drug or alcohol test
- •Smokers or subject with a positive result in smoking test
- •Subjects who have not passed 16 weeks since participation in another clinical trial
结局指标
主要结局
-
-Pharmacokinetic parameters -Adverse events
次要结局
未报告次要终点
研究者
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