JPRN-jRCT2080223231已完成1 期
Clinical Pharmacology Study of CS-3150 Evaluation of the effect of repeated dose of itraconazole orally administered to healthy Japanese adult male on the pharmacokinetics of CS-3150
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
When esaxerenone 2.5 mg was coadministered with itraconazole 200 mg, Cmax and AUC for esaxerenone increased by approximately 1.1 fold and 1.5-fold, respectively, compared to administration of esaxerenone alone. It was considered that there were no safety concerns when esaxerenone was administered concomitantly with itraconazole.
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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