JPRN-jRCT2071210058已完成1 期
A Phase 1 Study to Assess the Absorption, Metabolism, Elimination, and Mass Balance of Oral [14C] TAS-115 in Healthy Adult Male Subjects
Huang Jinhong0 个研究点目标入组 6 人开始时间: 2021年9月7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
- Male
入选标准
- •(1) Provided written informed consent
- •(2) Men aged 20 or older and younger than 40 years at the time of consent
- •(3) Weigh at least 50.0 kg at the time of screening tests with a body mass index (BMI, weight [kg]/[height {m}]2) ranging from 18.5 to < 25.0 kg/m2
- •(4) Vital signs 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) Pulse rate ranging from 40 to 99 beats/min
- •d) Body temperature (axilla) ranging from 35.0 to 37.0
- •(5) 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) Accompanying diseases considered inappropriate for participation in this study including hepatic diseases, renal diseases, gastrointestinal diseases, cardiovascular diseases, hematologic diseases, respiratory diseases, immunologic or allergic diseases, neurological or psychiatric diseases, metabolic or endocrinological diseases, or malignant tumors, or a history of these diseases
研究者
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