/ Active, not recruitingNot 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.
/ CompletedNot Applicable 利培酮口崩片在健康成年受试者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究
[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study of risperidone orodisintegrating tablets in healthy adult subjects under fasting and fed conditions
评估受试制剂利培酮口崩片与参比制剂在健康成年受试者空腹和餐后状态下的生物等效性研究
[Translation] A study to evaluate the bioequivalence of the test product, risperidone orodisintegrating tablets, and the reference product in healthy adult subjects under fasting and fed conditions
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