CTRI/2013/10/004114已完成1 期
Aqueous Humor Bioequivalence Study of Loteprednol 0.5 %, Sun Pharmaceutical Industries Ltd (SPIL) and Lotemax in Patients Undergoing Cataract Surgery: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Cross over, Active Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- Pharmacokinetic assessment
研究概览
简要总结
The study will be conducted to assess bioequivalence of SPIL’sloteprednol ophthalmic suspension to the reference listed drug in patients undergoingcataract surgery and to monitor the safety of the patients participating in thestudy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Men or women ≥18 years of age (no upper age limit mentioned in the protocol) -Willing to give informed consent -elected for cataract extraction.
排除标准
- •history of hypersensitivity to any of the components used in the preparation of the study drug -History of chronic or recurrent severe inflammatory eye disease.
结局指标
主要结局
Pharmacokinetic assessment
时间窗: Pre-dose, 30 min, 60 min, 90 min, 120 min, 240 min and 360 minutes
次要结局
- Safety(Visit 2 to Visit 6)
研究者
研究点 (3)
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