CTRI/2017/08/009210尚未招募不适用
A Multi-Centeric, Open-Label, Randomized, Cross-over, Aqueous Humor Bioequivalence Study of Loteprednol Etabonate Ophthalmic Suspension 0.5% (Sun Pharmaceutical Industries, Ltd.) and Lotemax® (Loteprednol Etabonate Ophthalmic Suspension 0.5%; Bausch & Lamb, Inc.) in Subjects With Indicated Bilateral Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 418
- 试验地点
- 17
- 主要终点
- 1.Pharmacokinetic parameter :(AUC0-6) and Cmax
研究概览
简要总结
This is open label Bioequivalence study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Willing and able to provide written informed consent prior to any study procedures being performed.
- •Ready and able to follow all instructions and attend all study visits.
- •3.Have planned bilateral cataract extraction
- •Agree to perform pregnancy test before participation in the trial 5.Agree to use an acceptable method of contraception for the duration of the study or not be of childbearing potential.
排除标准
- •1.Have any active ocular disease in either eye that requires prescription treatment 2.Have an active infection (bacterial, viral or fungal) of either eye or eyelids 3.Pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test.
- •4.use of an investigational drug or device within 30 days of Visit 1.
结局指标
主要结局
1.Pharmacokinetic parameter :(AUC0-6) and Cmax
时间窗: 1.Pharmacokinetic parameter : over a period of approximately 7 to 63 days
次要结局
未报告次要终点
研究者
研究点 (17)
Loading locations...
相似试验
已完成
不适用
Bioequivalence study to compare Xeloda and Capecitabine tablets in patients with colorectal cancer or breast cancerCTRI/2013/05/003665Biocad India Private Limited26
已完成
1 期
Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting ConditionsHealthyNCT01373138Dr. Reddy's Laboratories Limited34
已完成
1 期
Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed ConditionsHealthyNCT01506791Dr. Reddy's Laboratories Limited44
已完成
1 期
An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous RolapitantChemotherapy-induced Nausea and VomitingNCT02285647Tesaro, Inc.138
已完成
1 期
Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid TumorsAdvanced Solid TumorsExcluding Breast CancerNCT01421004Novartis Pharmaceuticals166