NCT00356850已完成1 期
Ocular Pharmacokinetics After a Single Drop Instillation, in Each Eye of One of Three Different Concentrations of T1225 (0.5% - 1% - 1.5% Dihydrate) in 91 Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 主要终点
- Area Under the Curve from 0 to 24 hours (AUC0-24h)
研究概览
简要总结
To evaluate azithromycin tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.
详细描述
The aim of the present study was to compare azithromycin tear ocular concentrations after a single instillation of three different T1225 concentrations in order to determine early azithromycin tear concentration and to assess the T1225 concentration, which allowed having the higher azithromycin tear concentration, 24 hours after a single instillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Male/female aged from 18 to 45 years;
- •Written informed consent;
- •Healthy volunteers without any subjective ocular symptom;
- •Corrected visual acuity >= 6/10;
- •Registered in the national register of healthy volunteers
排除标准
- •Ocular trauma, infection or inflammation within the last 3 months;
- •Conjunctival hyperaemia (score >= 2);
- •Folliculo-papillary conjunctivitis (score >= 2);
- •Topical ocular treatment within the last month;
- •Ocular surgery, including LASIK and PRK, within the last 12 months;
- •Other ocular laser within the last 3 months;
- •Zithromax® and Azadose® within the last 3 months;
- •Medication during the study (except: paracetamol, contraceptives
结局指标
主要结局
Area Under the Curve from 0 to 24 hours (AUC0-24h)
Concentration 24 hours after instillation (C24h)
Elimination half-life (t1/2)
Maximum Concentration (Cmax)
次要结局
- Tolerance
研究者
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