jRCT2051210203已完成不适用
Drug-drug interaction study to assess the effects of administration of clarithromycin or rifampicin on the pharmacokinetics of K-237 in healthy adult volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 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
- Crossover Assignment
- 主要目的
- Treatment Purpose
- 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) Subject is a healthy adult male volunteer.
- •(2) Subject is between the ages of 18 and 45 years at the time of signing informed consent.
- •(3) Subject has a body mass index of 17.6 to 26.4 kg/m2 at Screening.
排除标准
- •(1) Subject has used a drug (including over-the-counter drug, vaccination) within 14 days before the administration of the study drug in the first treatment period, or those who need to use it during the study period.
- •(2) Subject has received products containing St John's wort within 4 weeks before the administration of the study drug in the first treatment period. Subject has received supplements and products containing grapefruit within 14 days before the administration of the study drug in the first treatment period.
- •(3) Subject has a current malabsorption, and those who had an operation on the gastrointestinal tract that may affect absorption (excluding appendectomy).
结局指标
主要结局
-
Plasma pharmacokinetic parameters
次要结局
未报告次要终点
研究者
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