/ CompletedNot Applicable [Translation] Bioequivalence study of olopatadine hydrochloride granules in humans under fed conditions
主要研究目的:本研究以兰西哈三联制药有限公司生产的盐酸奥洛他定颗粒(规格:2.5mg)为受试制剂,以原研厂家協和キリン株式会社生产的盐酸奥洛他定颗粒【规格:0.5%(2.5mg/0.5g),商品名:Allelock®】为参比制剂,评价受试制剂和参比制剂在餐后条件下给药后的生物等效性。
次要研究目的:观察单次口服2.5mg的盐酸奥洛他定颗粒受试制剂或参比制剂在健康受试者中的安全性。
[Translation] Main research purpose: This study uses Olopatadine Hydrochloride Granules (Specification: 2.5 mg) produced by Lanxiha Sanlian Pharmaceutical Co., Ltd. as the test preparation, and Olopatadine Hydrochloride Granules [Specification: 0.5% (2.5 mg/0.5 g), trade name: Allelock®] produced by the original manufacturer Kyowa Kirin Co., Ltd. as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under postprandial conditions.
Secondary research purpose: To observe the safety of a single oral dose of 2.5 mg of Olopatadine Hydrochloride Granules test preparation or reference preparation in healthy subjects.
/ CompletedNot Applicable [Translation] Bioequivalence study of olopatadine hydrochloride granules in humans under fasting conditions
主要研究目的:本研究以兰西哈三联制药有限公司生产的盐酸奥洛他定颗粒(规格:2.5mg)为受试制剂,以原研厂家協和キリン株式会社生产的盐酸奥洛他定颗粒【规格:0.5%(2.5mg/0.5g),商品名:Allelock®】为参比制剂,评价受试制剂和参比制剂在空腹条件下给药后的生物等效性。
次要研究目的:观察单次口服2.5mg的盐酸奥洛他定颗粒受试制剂或参比制剂在健康受试者中的安全性。
[Translation] Main research purpose: This study used olopatadine hydrochloride granules (specification: 2.5 mg) produced by Lanxiha Sanlian Pharmaceutical Co., Ltd. as the test preparation, and olopatadine hydrochloride granules [specification: 0.5% (2.5 mg/0.5 g), trade name: Allelock®] produced by the original manufacturer Kyowa Kirin Co., Ltd. as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting conditions.
Secondary study objective: To observe the safety of a single oral administration of 2.5 mg of the test preparation or reference preparation of olopatadine hydrochloride granules in healthy subjects.
探索洛索洛芬钠凝胶贴膏治疗膝骨关节炎疼痛的有效性和安全性的多中心、随机、阳性药/安慰剂平行对照临床试验
[Translation] A multicenter, randomized, active/placebo-controlled clinical trial to explore the efficacy and safety of loxoprofen sodium gel patch in the treatment of knee osteoarthritis pain
主要目的:以阳性药、安慰剂为对照,探索评价洛索洛芬钠凝胶贴膏治疗膝骨关节炎的临床疗效。
次要目的:评价洛索洛芬钠凝胶贴膏在膝骨关节炎疼痛患者中的安全性。
[Translation] Primary objective: To explore and evaluate the clinical efficacy of loxoprofen sodium gel patch in the treatment of knee osteoarthritis using active drugs and placebo as controls.
Secondary objective: To evaluate the safety of loxoprofen sodium gel patch in patients with knee osteoarthritis pain.
100 Clinical Results associated with Medisan Pharmaceutical Co.,Ltd.LANXI
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100 Translational Medicine associated with Medisan Pharmaceutical Co.,Ltd.LANXI