Delving into the Latest Updates on Gansu Xifeng Pharmaceutical Co., Ltd. with Synapse

Overview

主要目的:以丽彩甘肃西峰制药有限公司生产的双氯芬酸二乙胺乳胶剂(规格:2.32%(30g:0.696g，以CI8HClN202计))为受试制剂，以GlaxoSmithKline Consumer Healthcare(UK)Trading Limited的双氯芬酸二乙胺乳胶剂(规格:2.32%(30g:0.696g，以CI8H2ClN20计))为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main purpose: Diclofenac diethylamine emulsion (specification: 2.32% (30g: 0.696g, calculated as CI8HClN202)) produced by Licai Gansu Xifeng Pharmaceutical Co., Ltd. was used as the test preparation, and diclofenac diethylamine emulsion (specification: 2.32% (30g: 0.696g, calculated as CI8H2ClN20)) produced by GlaxoSmithKline Consumer Healthcare (UK) Trading Limited was used as the reference preparation. According to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy subjects was investigated. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date01 Aug 2024

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Gansu Xifeng Pharmaceutical Co., Ltd.

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