[Translation] A single-center, randomized, open-label, fasting, single-dose, two-dose, three-sequence, three-period, partially repeated crossover bioequivalence study of diclofenac diethylamine emulsion in healthy adult Chinese subjects
主要研究目的:
考察空腹单次外用受试制剂双氯芬酸二乙胺乳胶剂(规格:1%[20g: 0.2g],海南全星制药有限公司生产,北京阳光诺和药物研究股份有限公司提供)与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],GSK Consumer Healthcare Schweiz AG持证,GSK Consumer Healthcare SARL生产,北京阳光诺和药物研究股份有限公司提供在中国成年健康受试者体内的药代动力学特征,评价空腹状态下外用两种制剂的生物等效性。
次要研究目的:
评价空腹单次外用受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the pharmacokinetic characteristics of the single-dose topical test preparation diclofenac diethylamine emulsion (specification: 1% [20g: 0.2g], produced by Hainan Quanxing Pharmaceutical Co., Ltd., provided by Beijing Sunshine Novo Pharmaceutical Research Co., Ltd.) and the reference preparation diclofenac diethylamine emulsion (trade name: Voltaren®, specification: 1% [20g: 0.2g], licensed by GSK Consumer Healthcare Schweiz AG, produced by GSK Consumer Healthcare SARL, provided by Beijing Sunshine Novo Pharmaceutical Research Co., Ltd.) in healthy adult Chinese subjects, and to evaluate the bioequivalence of the two topical preparations in the fasting state.
Secondary study objectives:
To evaluate the safety of the single-dose topical test preparation and the reference preparation in healthy adult Chinese subjects.