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临床试验/NCT05905653
NCT05905653已完成1 期

Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers

Santen Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年5月25日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
8
试验地点
1
主要终点
Maximum Plasma Concentration [Cmax]

研究概览

简要总结

To evaluate the safety and plasma pharmacokinetics of STN1012600 ophthalmic solution 0.002% (1 drop once daily for 7 days) in healthy adult male subjects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Subjects who can comply with scheduled visits and the examination and observation as specified in the clinical study protocol

排除标准

  • Subjects have a disease and/or abnormal laboratory value which is considered inappropriate from safety evaluation perspective
  • Subjects who are inappropriate as participants in this study in the opinion of the investigator or sub investigator

研究组 & 干预措施

STN1012600 0.002%

Experimental

干预措施: STN1012600 ophthalmic solution 0.002% (Drug)

结局指标

主要结局

Maximum Plasma Concentration [Cmax]

时间窗: 1 week, Day 1 and Day 7

Calculate plasma pharmacokinetic parameters and study pharmacokinetics.

次要结局

  • Area Under The Curve From Time Zero to the Last Sampling Time [AUC 0-t](1 week, Day 1 and Day 7)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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