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MechanismGABAA receptor agonists |
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Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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
[Translation] A Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of NORA520 tablets in healthy Chinese adult female subjects
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。
[Translation] To evaluate the safety and tolerability of NORA520 tablets in healthy Chinese female adult subjects; to evaluate the pharmacokinetic characteristics of NORA520 tablets in healthy Chinese female adult subjects.
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 Clinical Results associated with Gerbera Therapeutics, Inc.
0 Patents (Medical) associated with Gerbera Therapeutics, Inc.
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100 Translational Medicine associated with Gerbera Therapeutics, Inc.