JPRN-jRCT2080222640未知1 期
A Single-center, Single- and Multiple-Dose Phase 1 Study to Evaluate the Safety and Pharmacokinetics of TAK-114 in Healthy Adult Japanese and Caucasian Male Subjects
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 82 人开始时间: 2014年10月28日最近更新:
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 82
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 <= 45age old（—）
- 性别
- Male
入选标准
- •Healthy Japanese Subjects:
- •- All subjects must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
- •- Male subjects aged 20 to 45 years, inclusive.
- •- All subjects should weigh at least 45 kg (99 lb) and have a body mass index between 18.5 and 25.0 kg/m2.
- •Healthy Caucasian Subjects:
- •- All subjects must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
- •- Male subjects aged 20 to 45 years, inclusive; are of Caucasian descent (born to Caucasian parents and grandparents and has lived outside original country for less than 5 years) and maintains their original diet and lifestyle.
- •- All subjects should weigh at least 45 kg (99 lb) and have a body mass index between 18.5 and 30.0 kg/m2.
排除标准
- •- Subjects have a known hypersensitivity to any component of the formulation of TAK-114 or any herb medicine or supplement related to Indigo naturalis.
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