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MechanismmAChRs antagonists |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.South Korea |
First Approval Date03 Mar 1964 |
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MechanismCOX-2 inhibitors |
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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.
/ Not yet recruitingPhase 3 甲磺酸酚妥拉明滴眼液逆转健康参与者由药物诱导的瞳孔散大的临床有效性和安全性的多中心、随机、双盲、安慰剂对照III期临床试验
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial of the efficacy and safety of phentolamine mesylate eye drops in reversing drug-induced mydriasis in healthy participants.
主要目的:
评价甲磺酸酚妥拉明滴眼液逆转健康参与者由药物诱导的瞳孔散大的有效性。
次要目的:
评价甲磺酸酚妥拉明滴眼液逆转健康参与者由药物诱导的瞳孔散大的安全性;
评价甲磺酸酚妥拉明滴眼液逆转健康参与者由药物诱导的瞳孔散大的药代动力学(PK)特征。
[Translation] Primary objective: To evaluate the efficacy of phentolamine mesylate eye drops in reversing drug-induced mydriasis in healthy participants.
Secondary objectives: To evaluate the safety of phentolamine mesylate eye drops in reversing drug-induced mydriasis in healthy participants; to evaluate the pharmacokinetic (PK) characteristics of phentolamine mesylate eye drops in reversing drug-induced mydriasis in healthy participants.
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