JPRN-jRCT2071210008已完成1 期
A phase 1 open-label study evaluating the pharmacokinetics and mass balance of [14C] TAS-205 in healthy volunteers
asermoaddeli Ali0 个研究点目标入组 6 人开始时间: 2021年4月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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
- >= 20age old 至 < 40age old（—）
- 性别
- All
入选标准
- •(1) Healthy adult male subjects who provided written informed consent to participate in the study
- •(2) Aged 20 years or older and younger than 40 years at the time of informed consent
- •(3) Capable of oral intake.
- •(4) Body weight of 50 kg or more and body mass index of 18.5 or more and less than 25.0
排除标准
- •(1) Had current or previous hypersensitivity or allergy to drugs
- •(2) Had current or previous drug abuse (including use of illicit drugs) or alcoholism
- •(3) 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)
- •(4) Consumed foods or beverages containing the St. John's Wort within 28 days before study drug administration
- •(5) Had blood pressure, pulse rate, and body temperature meeting any of the following at screening:
- •Systolic blood pressure: <90 mmHg or >=140 mmHg
- •Diastolic blood pressure: <40 mmHg or >=90 mmHg
- •Pulse rate: <40 beats per minute (bpm) or >=100 bpm
- •Body temperature: 35.0 or >= 37.1
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