NCT00407589已完成1 期
Systemic Pharmacokinetics of BOL-303224-A After Single and Multiple Instillations of BOL-303224-A in Subjects With Suspected Bacterial Conjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing
研究概览
简要总结
This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in participants with bacterial conjunctivitis. The purpose of this study is to determine the extent of systemic exposure to BOL-303224-A following single and multiple topical administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must be at least 18 years of age, any race
- •must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in both eyes
- •women of childbearing potential must utilize reliable contraceptive methods and have a negative pregnancy test
排除标准
- •Pregnant or nursing women
- •known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medication
- •use of any antibiotic within 72 hours of enrollment
- •participation in an ophthalmic drug or devise research study within 30 days prior to entry in this study
研究组 & 干预措施
BOL-303224-A
Experimental
Systemic exposure of BOL-303224-A following single and multiple topical doses
干预措施: BOL-303224-A (Drug)
结局指标
主要结局
Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing
时间窗: Blood samples will be collected from 0 to 6 hours on Day 1 and from 0 to 12 hours on Day 6. There will be additional sampling times at 0 hours on Day 2-5.
次要结局
- Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection(Througout the study)
研究者
研究点 (1)
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