A Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety of AC-170 0.24%
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- T 1/2 values of AC 170 0.24%
研究概览
简要总结
The purpose of this study is to evaluate the Plasma Pharmacokinetics and Safety of AC 170 0.24% in Healthy, Adult Subjects when used twice daily for one week.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 and no older than 55 years of age
- •be able to self-administer eye drops or have a parent/legal guardian available for this purpose
- •have blood and urine analysis within normal limits
- •have ocular health within normal limits
排除标准
- •known contraindications or sensitivities to the study medication or its components
- •have any active systemic or ocular disorder (other than refractive disorder)
- •have inability to comply with controlled diet
- •have used prescription or non prescription drugs within washout period and throughout study
- •have used alcohol or tobacco within the washout period
研究组 & 干预措施
AC 170 0.24%
干预措施: AC 170 0.24% (Drug)
结局指标
主要结局
T 1/2 values of AC 170 0.24%
时间窗: 1 week
Plasma samples will be drawn at specified time points and then analyzed to determine T 1/2 values of AC 170 0.24% in the plasma
Cmax values of AC 170 0.24%
时间窗: 1 week
Plasma samples will be drawn at specified time points and then analyzed to determine Cmax values of AC 170 0.24% in the plasma
Tmax values of AC 170 0.24%
时间窗: 1 week
Plasma samples will be drawn at specified time points and then analyzed to determine Tmax values of AC 170 0.24% in the plasma
AUC values of AC 170 0324%
时间窗: 1 week
Plasma samples will be drawn at specified time points and then analyzed to determine AUC values of AC 170 0.24% in the plasma
次要结局
未报告次要终点