JPRN-jRCT2080222780已完成1 期
An open-label, single-sequence crossover study to evaluate the effects of CS-3150 on the pharmacokinetics of midazolam in Japanese healthy subjects
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 28 人开始时间: 2015年3月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
Esaxerenone increased midazolam Cmax and AUC by approximately 1.2 fold compared to administration of midazolam alone. It was considered that there were no safety concerns when midazolam was administered concomitantly with esaxerenone.
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. Male Japanese
- •2. Between the age of 20 and 45
- •3. Between the BMI of 18.5 and 24.9
- •4. Sitting blood pressure : systolic blood pressure < 140 mmHg, and diastolic blood pressure < 90 mmHg
- •5. Pulse rate <=99 bpm
排除标准
- •1. Presence or history of hypersensitivity or idiosyncratic reaction (penicillin allergy etc.) to a drug including midazolam.
- •2. Presence or history of drug or alcohol dependence. etc.
研究者
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