NCT00564447已完成4 期
A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Conjunctiva of Healthy Volunteers Following a Single Ocular Administration
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Assessment of Pharmacokinetic Parameters
研究概览
简要总结
The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart
排除标准
- •Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial
- •Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)
- •Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures
- •Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies
- •Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study
研究组 & 干预措施
Azithromycin-30 minutes Post dose
Experimental
干预措施: Azithromycin (Drug)
Azithromycin-2 hours post dose
Experimental
干预措施: Azithromycin (Drug)
Azithromycin-12 hours post dose
Experimental
干预措施: Azithromycin (Drug)
Azithromycin-24 hours post dose
Experimental
干预措施: Azithromycin (Drug)
Moxifloxacin-30 minutes post dose
Experimental
干预措施: Moxifloxacin (Drug)
Moxifloxacin-2 hours post dose
Experimental
干预措施: Moxifloxacin (Drug)
Moxifloxacin-12 hours post dose
Experimental
干预措施: Moxifloxacin (Drug)
Moxafloxacin-24 hours post dose
Experimental
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Assessment of Pharmacokinetic Parameters
时间窗: Over 24 hours
Conjunctiva Concentration of Azithromycin and Moxifloxacin
次要结局
未报告次要终点
研究者
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