CTRI/2016/01/006491Other1 期
A RANDOMIZED, OPEN LABEL, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE, MULTIPLE DOSE, CROSSOVER, COMPARATIVE PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF BRIMONIDINE TARTRATE OPHTHALMIC SUSPENSION 0.35% (OD ADMINISTRATION) OF SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED, INDIA, AND ALPHAGAN® P (BRIMONIDINE TARTRATE) OPHTHALMIC SOLUTION 0.1% (TID ADMINISTRATION) OF ALLERGAN, INC., IN 40 HEALTHY HUMAN ADULT SUBJECTS
试验速览
- 阶段
- 1 期
- 状态
- Other
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Willingness and availability of subject to give written informed consent and adhere to protocol requirements throughout the study period. -Subjects between 18- 45 years male/female of age
- •IOP not more than 21 mmHg in both the eyes.
- •-Subjects whose screening laboratory values are within normal limits or considered by the Investigator/sub-Investigator to be of no clinical significance
排除标准
- •-History of allergic hypersensitivity or poor tolerance to any of the components of the preparations used in this study
- •-Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy
- •-Progressive retinal or optic nerve disease
- •-History of chronic or recurrent severe inflammatory eye disease
研究者
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