|
MechanismmAChRs antagonists |
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Japan |
First Approval Date20 Jul 1968 |
|
MechanismCOX-2 inhibitors |
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Progression of Myopia in Children and Adolescents in a Randomized, Double-blind, Placebo Parallel-controlled, Multicenter, Phase III Clinical Trial
The clinical trial aims to test the effectiveness and safety of two low-dose atropine sulfate eye drops for delaying myopia progression in children and adolescents.
Primary Objective: evaluate the effectiveness of 0.01% and 0.02% atropine sulfate eye drops for 96 weeks compared to placebo in delaying myopia progression in children and adolescents. Secondary Objective: evaluate the safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) in delaying myopia progression in children and adolescents.
Exploratory Objective:
1. the efficacy and safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) for 144 weeks.
2. evaluate the rebound effect of two low-concentration atropine sulfate eye drops (0.01%/0.02%) after discontinuation.
/ CompletedNot Applicable [Translation] Bioequivalence study of calcium dobesilate tablets in healthy volunteers (fasting)
主要试验目的:在中国健康受试者中评价单次空腹服用宁夏康亚药业股份有限公司生产的羟苯磺酸钙片0.5g(规格:0.25g/片;受试制剂)和OMpharma S.A.生产的羟苯磺酸钙片500mg(商品名:Doxium;规格:250mg/片;参比制剂)的生物等效性;
次要试验目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary study objective: To evaluate the bioequivalence of a single fasting dose of 0.5 g calcium dobesilate tablets (specification: 0.25 g/tablet; test preparation) produced by Ningxia Kangya Pharmaceutical Co., Ltd. and 500 mg calcium dobesilate tablets (trade name: Doxium; specification: 250 mg/tablet; reference preparation) produced by OMPharma S.A. in healthy Chinese subjects;
Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Seefunge Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Seefunge Pharmaceutical Technology Co., Ltd.
100 Deals associated with Seefunge Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Seefunge Pharmaceutical Technology Co., Ltd.