JPRN-jRCT2080225244已完成1 期
Pharmacokinetics and safty of KRP-AM1977Y in healthy adult volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
The plasma concentration trough values of AM-1977 and AM2012-008 when KRP-AM1977Y 150mg (300mg on the first day) was administered for 7 days ranged from 0.771 to 0.915 and 0.0789 to 0.0887ug/mL, respectively. On day 7, Cmax of AM-1977 and AM2012-008 was 2.92, 0.124ug/mL and AUC was 35.4, 2.48ug*h/mL, respectively. The urinary excretion rates of AM-1977 and AM2012-008 were 17.5%, 27.4%. No clinically significant safety finding was reported.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 40age old(—)
- 性别
- Male
入选标准
- •Person with BMI that is more than 18.5 but less than 25.0, etc.
排除标准
- •Have a history of allergy or severe side effects to quinolone antibiotics.
研究者
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