JPRN-jRCT2080223421已完成1 期
A Phase 1 Study of CS-3150 Evaluation of Safety, Pharmacokinetics, and Pharmacodynamics after Multiple Oral Administration in Japanese Healthy Adult Male Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
Esaxerenone was well tolerated in multiple oral administration of the drug at doses of 10 mg to 100 mg once daily for 10 days in Japanese healthy male subjects.
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
- •1)Japanese male
- •2)Persons >= 20 years and =< 45 years of age at the time of informed consent
- •3)Persons with a body mass index (BMI; calculated by body weight [kg]/height [m]2) of >= 18.5 kg/m2 and < 25.0 kg/m2 at the screening examination
排除标准
- •1)Persons with hypersensitivity or idiosyncratic reactions to a drug, (such as penicillin allergy)
- •2)Persons with drug or alcohol dependence
研究者
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