NCT05729594已完成1 期
Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers
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
- 40
- 试验地点
- 1
- 主要终点
- Plasma concentrations of bimatoprost and bimatoprost free acid at each timepoint (in ng/mL)
研究概览
简要总结
This study is being performed to compare the systemic pharmacokinetic profiles of T4032 and Lumigan 0.01% given that T4032 has a different formulation (in terms of excipients) from the reference product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Informed consent signed and dated
- •Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study
- •Participants with no ocular symptoms
排除标准
- •History of ocular trauma, infection, or inflammation within the last 3 months
- •Presence of an ocular pathology such as blepharitis, conjunctivitis, uveitis, or any other ocular infection or inflammation
- •IOP <10 mmHg or >21 mmHg
研究组 & 干预措施
T4032
Experimental
干预措施: Bimatoprost Ophthalmic (Drug)
Lumigan
Active Comparator
干预措施: Bimatoprost Ophthalmic (Drug)
结局指标
主要结局
Plasma concentrations of bimatoprost and bimatoprost free acid at each timepoint (in ng/mL)
时间窗: at 2 timepoint : Baseline and week 2
Ocular and systemic adverse events
时间窗: up to week 2
次要结局
未报告次要终点
研究者
研究点 (1)
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