JPRN-jRCT2080223388已完成1 期
Clinical Pharmacology Study of CS-3150 Drug-drug interaction Study between CS-3150 and digoxin or rifampicin in healthy Japanese subjects.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
In study 1, digoxin Cmax at steady state was increased by 1.13 fold when digoxin 0.25 mg was coadministered with esaxerenone 5 mg. However, digoxin Ctrough and AUC were not increased. In study 2, esaxerenone Cmax and AUC were decreased by 0.31 fold and 0.66 fold, respectively, when esaxerenone 5 mg was coadministered with rifampicin 600 mg. It was considered that there were no safety concerns when esaxerenone was coadministered with either digoxin or amlodipine.
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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