NCT02039765已完成1 期
A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in Healthy, Adult Subjects.
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
- 12
- 试验地点
- 1
- 主要终点
- Plasma Levels
研究概览
简要总结
To characterize the plasma pharmacokinetics and safety profile of brimonidine following a single dose and 4 times per day (QID) dosing of brimonidine tartrate ophthalmic solution 0.025% for 7 days in healthy, adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- •have ocular health within normal limits.
- •have blood (hematology, blood chemistry) and urine analysis within normal limits.
- •have a body weight within 15% of ideal weight
排除标准
- •have known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medications required by the protocol;
- •have any active systemic or ocular disorder other than refractive disorder.
- •have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that in the Investigator's opinion could affect ophthalmic drop absorption.
- •have a history of chronic alcohol consumption.
- •consume alcohol and/or caffeine or xanthine containing products within 48 hours prior to dosing at Visit 1 or anticipated use during the study.
- •have a history of tobacco, nicotine, or nicotine containing product use within the last year prior to Visit 2;
- •have significant weight change (over 10 pounds) within the 60 days prior to Visit 2;
- •have blood donation or equivalent blood loss of 450 ml or more, within 60 days prior to Visit 2;
- •have an abnormal blood pressure (defined as ≤ 90 or ≥ 160 (systolic) measured in mmHg or ≤ 60 or ≥ 100 (diastolic) measured in mmHg);
- •have intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.
研究组 & 干预措施
Brimonidine tartrate
Experimental
One drop of brimonidine tartrate ophthalmic solution 0.025% in each eye once at Visit 2 (Day 1) then four times daily (QID) approximately 4 hours apart at Visit 3 (Day 2) through day 6, and then once at Visit 4 (Day 7).
干预措施: Brimonidine tartrate (Drug)
结局指标
主要结局
Plasma Levels
时间窗: Day 8 (Visit 5)
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 8.
次要结局
- Hematology and Blood Chemistry Analysis(Day 8 (Visit 5))
- Urinalysis(Day 8 (Visit 5))
- Visual Acuity(Day 8 (Visit 5))
- Slit Lamp Biomicroscopy(Day 8 (Visit 5))
- Intraocular Pressure(Baseline (Visit 1))
研究者
研究点 (1)
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