JPRN-jRCT2080225163已完成1 期
KRP-AM1977X Phase I Clinical Study -Examination of safety, pharmacokinetics and effects on gut microbiome after single and repeated oral administration in healthy adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
研究概览
简要总结
In a phase I clinical study of KRP-AM1977X in healthy Japanese adult males, the safety of KRP-AM1977X was not significantly affected in a single oral dose study up to 800 mg and in a repeated oral dose study up to 400 mg once daily for 7 days, confirming its tolerability.
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
- •Drug allergy (including drug allergy to mydriatic agent), food allergy or atopy, and those who have a history of it
研究者
相似试验
已完成
1 期
Phase I Study of RO7105705 in HV/AD patientsAlzheimer's diseaseJPRN-jRCT2080224616Chugai Pharmaceutical Co., Ltd.30
已完成
1 期
KRP-AM1977X QT/QTc studyHealthy volunteersJPRN-jRCT2080222958Kyorin Pharmaceutical Co., Ltd.60
已完成
1 期
Phase I study of KRP-AM1977Y-JPRN-jRCT2080225244Kyorin Pharmaceutical Co., Ltd.18
已完成
3 期
KRP-AM1977X Phase III Comparative Study (sinusitis)Sinusitis (severity of infection: moderate to severe)JPRN-jRCT2080222862Kyorin Pharmaceutical Co.,LTD279
已完成
3 期
Open-label study for the patients with otorhinolaryngological infectionJPRN-jRCT2080222863Kyorin Pharmaceutical Co.,LTD70