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临床试验/JPRN-jRCT2080225244
JPRN-jRCT2080225244已完成1 期

Pharmacokinetics and safty of KRP-AM1977Y in healthy adult volunteers

Kyorin Pharmaceutical Co., Ltd.0 个研究点目标入组 18 人开始时间: 2020年6月25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
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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