JPRN-jRCT2080223397已完成1 期
Clinical Pharmacology Study of CS-3150 A single dose study to assess the absolute bioavailability and effect of food on the pharmacokinetics of CS-3150 in Japanese healthy subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
Absolute bioavailability of a single oral 5-mg dose of esaxerenone in healthy Japanese subjects was 89.0% in the fasting state and 90.8% in the postprandial state. Food intake does not affect esaxerenone PK. Additionally, no safety concerns were identified.
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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