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MechanismCD11a antagonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date11 Jul 2016 |
Target- |
Mechanism- |
Active Org.- |
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Active Indication- |
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Drug Highest PhasePending |
First Approval Ctry. / Loc.- |
First Approval Date- |
立他司特滴眼液在健康受试者体内的药代动力学和安全性试验
[Translation] Pharmacokinetics and safety study of lifalast eye drops in healthy volunteers
主要目的:比较成都康弘药业集团股份有限公司研制的立他司特滴眼液与Xiidra®在健康受试者中单次给药后泪液中的药代动力学特征。
次要目的:比较立他司特滴眼液与Xiidra®在健康受试者中单次给药后血浆中的药代动力学特征;观察立他司特滴眼液在健康受试者中单次给药的安全性。
[Translation] Primary objective: To compare the pharmacokinetic characteristics of lifalast eye drops developed by Chengdu Kanghong Pharmaceutical Group Co., Ltd. and Xiidra® in tears after a single dose in healthy subjects.
Secondary objective: To compare the pharmacokinetic characteristics of lifalast eye drops and Xiidra® in plasma after a single dose in healthy subjects; to observe the safety of a single dose of lifalast eye drops in healthy subjects.
立他司特滴眼液在健康受试者体内的安全性及药代动力学特征的临床试验
[Translation] Clinical trial on the safety and pharmacokinetic characteristics of lifalast eye drops in healthy subjects
主要目的:评价立他司特滴眼液在中国健康受试者中给药后的药代动力学特征。
次要目的:评价立他司特滴眼液在中国健康受试者中给药后的安全性。
[Translation] Primary objective: To evaluate the pharmacokinetic characteristics of lifalast eye drops after administration in healthy Chinese subjects.
Secondary objective: To evaluate the safety of lifalast eye drops after administration in healthy Chinese subjects.
立他司特滴眼液用于治疗干眼症的有效性和安全性的多中心、随机、双盲、安慰剂对照的 III 期临床试验
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial on the efficacy and safety of lifalast eye drops in the treatment of dry eye
通过测量在治疗 84 天后,试验组和安慰剂组下角膜荧光素染色评分(ICSS)较基线的改变均值,评估立他司特滴眼液与安慰剂相比在改善干眼症(DED)体征方面的疗效。
[Translation] The efficacy of lisdenafil eye drops in improving signs of dry eye disease (DED) compared with placebo was evaluated by measuring the mean change from baseline in the corneal fluorescein staining score (ICSS) in the experimental group and the placebo group after 84 days of treatment.
100 Clinical Results associated with Chengdu Push Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Chengdu Push Pharmaceutical Co., Ltd.
100 Deals associated with Chengdu Push Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Chengdu Push Pharmaceutical Co., Ltd.