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临床试验/JPRN-jRCT2080223324
JPRN-jRCT2080223324已完成1 期

Clinical Pharmacology Study of CS-3150 Drug-drug interaction study between CS-3150 and amlodipine in healthy Japanese subjects

DAIICHI SANKYO Co.,Ltd.0 个研究点目标入组 44 人开始时间: 2016年9月20日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
44

研究概览

简要总结

In study 1, the pharmacokinetics of esaxerenone was not affected by amlodipine when esaxerenone 2.5 mg was coadministered with amlodipine 10 mg. In study 2, AUC for amlodipine was increased by approximately 1.2 fold, but Cmax for amlodipine was not increased when amlodipine 2.5 mg was coadministered with esaxerenone 5 mg. It was considered that there were no safety concerns when esaxerenone was administered concomitantly with 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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