[Translation] A randomized, open-label, single-dose, two-formulation, three-sequence, three-period, semi-repeated crossover controlled trial designed to evaluate the bioequivalence of diclofenac diethylamine emulsion for topical use in healthy Chinese subjects in the fasting state.
主要目的:以山西泽辰医药科技有限公司提供的双氯芬酸二乙胺乳胶剂为受试制剂,按生物等效性试验的有关规定,与Haleon Schweiz AG持证的双氯芬酸二乙胺乳胶剂(参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
[Translation] Main objective: To investigate the bioequivalence of the two preparations in healthy volunteers by comparing the absorption rate and extent of diclofenac diethylamine emulsion provided by Shanxi Zechen Pharmaceutical Technology Co., Ltd. with that of diclofenac diethylamine emulsion (reference preparation) certified by Haleon Schweiz AG, using diclofenac diethylamine emulsion provided by Shanxi Zechen Pharmaceutical Technology Co., Ltd. as the test preparation according to the relevant regulations of bioequivalence studies.