JPRN-jRCT2071220117已完成1 期
A Drug-Drug Interaction Study of TAS5315 with CYP3A inhibitor in Healthy Adult Subjects
asermoaddeli Ali0 个研究点目标入组 20 人开始时间: 2023年3月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 40age old（—）
- 性别
- All
入选标准
- •1) Aged 18 or older and younger than 40 years at the time of consent
- •2) Weigh at least 45.0 kg at the time of screening tests with a body mass index (BMI, weight [kg]/[height {m}]2) ranging from 18.0 to < 25.0 kg/m2
- •3) Blood pressure and body temperature obtained in screening tests within the following ranges
- •a Systolic blood pressure (in supine position), 90 to 139 mmHg
- •b Diastolic blood pressure (in supine position), 40 to 89 mmHg
- •c Body temperature ranging from 35.0 to 37.4
- •4) Judged to be healthy by the investigator based on the examination findings (subjective symptoms and objective findings), blood pressure, pulse rate, body temperature, 12-lead ECG, and laboratory tests (hematology test, biochemistry test, and urinalysis) at the time of screening tests
排除标准
- •1) Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded)
- •2) Had any severe disease history that may recur during the study period.
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