Tear Concentrations and Pharmacokinetics of Azithromycin Following Topical Administration of a Single Dose of Azithromycin Eyedrops in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- the maximum concentration (Cmax)
研究概览
简要总结
To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers.
详细描述
In this randomized, open, single-center study, 42 healthy volunteers will receive one drop of azithromycin into each eye. Azithromycin tear concentrations will be measured by LC-MS/MS at seven time points for 24 hours. Tolerability is evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 45 years old, male or female;
- •BMI in the range of 19 to 24;
- •eyes corrected visual acuity should be ≥ 1.0, intraocular pressure, slit lamp and fundus examination were normal, tear secretion function is normal;
- •Good compliance and voluntarily signed consent.
排除标准
- •Have eye disease or systemic disease;
- •physical examination, laboratory tests, ECG and chest X-ray examination abnormalities and has clinical significance;
- •HBsAg, anti-HCV, anti-HIV and TPPA positive;
- •those who used eye drops two weeks before the test and who used any dosage form of azithromycin;
- •known to azithromycin or macrolide-related varieties of allergies or serious adverse reactions;
- •need to wear contact lenses during the test;
- •history of internal surgery or laser surgery history;
- •participated in other drug clinical trials in the past three months;
- •pregnant women and lactating women, or in the growth period without taking effective contraceptive measures, menstrual period women;
- •mental illness or alcohol, history of drug abuse or inability to collaborate;
- •Any other circumstances that the investigators consider are unfit to participate in this study.
研究组 & 干预措施
azithromycin eyedrop
Each of the subjects' eyes will receive single dose of azithromycin eyedrops and then attribute the time for tear sampling at seven time points up to 24 hours.
干预措施: azithromycin eyedrop (Drug)
结局指标
主要结局
the maximum concentration (Cmax)
时间窗: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
The tear samples are taken at 7 time points after administration up to 24 hours.The Cmax is calculated at the average concentration of each point.
area under the curve (AUC)
时间窗: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
The tear samples are taken at 7 time points after administration up to 24 hours.The AUC is calculated at the average concentration of each point.
次要结局
- AEs(24 hours)
研究者
Xiuli Zhao
Prof.
Beijing Tongren Hospital