JPRN-jRCT2080225074已完成1 期
KRP-AM1977X Phase I Clinical Study Pharmacokinetics and Safety in Patients with Renal Dysfunction
Kyorin Pharmaceutical Co.,Ltd.0 个研究点目标入组 23 人开始时间: 2020年2月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
研究概览
简要总结
Decreased renal function had little effect on the blood kinetics of AM-1977 after a single oral dose of KRP-AM1977X 75 mg in the groups with mild, moderate and severe renal impairment. It was considered that AM-1977 showed almost the same kinetics as in the normal group even in patients with decreased renal function. In addition, there was no effect of decreased renal function on the occurrence of adverse events or the results of laboratory tests, etc.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Person with BMI that is more than 18.5 but less than 30.0, etc.
排除标准
- •Have a history of allergy or severe side effects to quinolone antibiotics.
研究者
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