jRCT2031240671招募中不适用
Drug-drug interaction study of Foscenvivint with CYP3A inhibitors in Healthy Male Volnteers (The phase I study).
OHARA Pharmaceutical Co.,Ltd.0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 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
- Non-randomized Controlled Trial
- 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
- 18age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •1: Healthy Japanese male subjects.
- •2: Age at the time of obtaining written informed consent is >=18 to <=45 years old.
- •3: Subjects who are capable of fully understanding the clinical trial and providing written informed consent.
排除标准
- •1: Subjects with any clinilcal abnormality assessed by the investigator or sub-investigator in laboratory tests, vital signs, or 12-lead ECG in eligibility test.
- •2: Subjects with a QTcF of >450 msec on a 12-lead ECG in the eligibility test.
- •3: Subjects who weighs <50.0 kg in the eligibility test.
结局指标
主要结局
-
Pharmacokinetics
次要结局
未报告次要终点
研究者
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