Hainan Zicheng Zhongtou Biotechnology Co., Ltd.

Healthy Chinese subjects were used as test subjects. A self-cross-controlled experimental design was adopted to determine the time course of diclofenac concentration in plasma of healthy subjects after administration of the test formulation of diclofenac diethylamine emulsion, and to estimate the corresponding pharmacokinetic parameters. Diclofenac diethylamine emulsion [trade name: Voltaren, specification: 1% (20 g: 0.2 g, calculated as diclofenac sodium)] certified by GSK Consumer Healthcare Schweiz AG and produced by GSK Consumer Healthcare SARL was used as a reference to evaluate the bioequivalence between the preparations and observe the safety of diclofenac diethylamine emulsion in healthy Chinese subjects.

Main research objectives: Using Abidor Hydrochloride Tablets (Specification: 50mg, Owner: Hainan Zicheng Zhongtou Biotechnology Co., Ltd., produced by Huayi Taikang Pharmaceutical Co., Ltd.) provided by Hainan Zicheng Zhongtou Biotechnology Co., Ltd. as the test preparation, and the reference preparation Abidor Hydrochloride Tablets (Specification: 50mg, Trade Name: Арбидол®, Ｆармстандарт-Лексредства licensed), the relative bioavailability of the two preparations in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary research objectives: Evaluate the safety of the single oral fasting/postprandial test preparation and reference preparation in healthy Chinese adult subjects.

Main study objectives: To investigate the relative bioavailability of a single single-dose (fasting) test preparation leprocaine cream 15g (specification: 5g/tube (each gram contains 25mg prilocaine and 25mg lidocaine), produced by Jiangxi Decheng Pharmaceutical Co., Ltd. and provided by Hainan Zicheng Zhongtou Biotechnology Co., Ltd.) and the reference preparation leprocaine cream 15g (Emla®, specification: 5g/tube (each gram contains 25mg prilocaine and 25mg lidocaine), certified by AstraZeneca AB) in healthy Chinese humans, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference basis for the application and clinical use of the drug. Secondary study objectives: To evaluate the safety of a single fasting use of the test preparation and the reference preparation in healthy adult Chinese subjects.