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非在研适应症- |
最高研发阶段临床2期 |
首次获批国家/地区- |
首次获批日期- |
评价 NORA520 片在中国健康成人女性受试者中的安全性、耐受性和药代动力学特征的 I 期临床研究
评价 NORA520 片在中国健康成人女性受试者中的安全性和耐受性;评价 NORA520 片在中国健康成人女性受试者中的药代动力学特征。
A Randomized, Placebo-Controlled, Double-Blinded, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Oral NORA520 in Female Adults With Severe Postpartum Depression
The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine:
* How well NORA520 is tolerated and what side effects it may cause
* If NORA520 reduces depressive symptoms in subjects with severe PPD
* The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken
* In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days.
100 项与 Gerbera Therapeutics, Inc. 相关的临床结果
0 项与 Gerbera Therapeutics, Inc. 相关的专利(医药)
100 项与 Gerbera Therapeutics, Inc. 相关的药物交易
100 项与 Gerbera Therapeutics, Inc. 相关的转化医学