[Translation] Bioequivalence trial of diclofenac diethylamine emulsion in Chinese healthy subjects with randomized, open, crossover design
主要研究目的:按有关生物等效性试验的规定,选择 GSK Consumer Healthcare Schweiz AG 持证的双氯芬酸二乙胺乳胶剂(商品名:扶他林®,规格:1%(20g:0.2g,以 C14H10Cl2NNaO2计))为参比制剂,对江苏万高药业股份有限公司生产 并 提 供 的 受 试 制 剂 双 氯 芬 酸 二 乙 胺 乳 胶 剂 ( 规 格 : 1% ( 20g:0.2g , 以C14H10Cl2NNaO2 计))进行空腹外用条件下人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹外用条件下的生物等效性。
次要研究目的:观察健康受试者外用受试制剂双氯芬酸二乙胺乳胶剂(规格:1%(20g:0.2g,以 C14H10Cl2NNaO2计))和参比制剂双氯芬酸二乙胺乳胶剂(商品名:扶他林®,规格:1%(20g:0.2g,以 C14H10Cl2NNaO2计))的安全性及外用刺激性情况。
[Translation] Main research purpose: According to the regulations on bioequivalence testing, select diclofenac diethylamine emulsion certified by GSK Consumer Healthcare Schweiz AG (trade name: Voltaren®, specification: 1% (20g: 0.2g, calculated as C14H10Cl2NNaO2) ) was used as a reference preparation. The test preparation diclofenac diethylamine emulsion (specification: 1% (20g:0.2g, calculated as C14H10Cl2NNaO2)) produced and provided by Jiangsu Wangao Pharmaceutical Co., Ltd. was tested for external use on the human body under fasting conditions. The bioequivalence test is to compare the absorption rate and extent of the drug in the test preparation with the reference preparation to see if the difference is within the acceptable range, and to evaluate the bioequivalence of the two preparations under fasting external use conditions.
Secondary research purpose: To observe the external use of the test preparation diclofenac diethylamine emulsion (specification: 1% (20g:0.2g, calculated as C14H10Cl2NNaO2)) and the reference preparation diclofenac diethylamine emulsion (trade name: Voltaren®, specification: 1% (20g:0.2g, calculated as C14H10Cl2NNaO2)) safety and external irritation.