GuangDong Junkang Pharmaceutical Co., Ltd.

Main purpose: This study used ilaprazole enteric-coated tablets (specification: 5 mg) produced by Guangdong Junkang Pharmaceutical Co., Ltd. as the test preparation. According to the relevant provisions of bioequivalence studies, ilaprazole enteric-coated tablets (specification: 5 mg, trade name: Yilian®) produced by the original manufacturer, Livzon Pharmaceutical Factory of Livzon Group, were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under postprandial conditions. Secondary purpose: To observe the safety of the test preparation ilaprazole enteric-coated tablets and the reference preparation ilaprazole enteric-coated tablets (Yilian®) in healthy subjects.

Primary objective: This study aims to investigate the pharmacokinetic characteristics of diclofenac diethylamine emulsion (2.32% (50 g: 1.16 g, calculated as C18H22Cl2N2O2)) developed by Guangdong Junkang Pharmaceutical Co., Ltd. and produced by Ruihua (Zhongshan) Pharmaceutical Co., Ltd. after a single fasting application in healthy study participants; diclofenac diethylamine emulsion (Voltarol®, 2.32% (50 g: 1.16 g, calculated as C18H22Cl2N2O2)) licensed by Haleon UK Trading Limited and produced by Haleon UK Trading Services Limited was used as the reference preparation to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations and evaluate the bioequivalence of the two preparations in humans. Secondary objective: To observe the safety of the test preparation and the reference preparation after a single application in healthy study participants.

This study used ilaprazole enteric-coated tablets (specification: 5 mg) produced by Guangdong Junkang Pharmaceutical Co., Ltd. as the test preparation. According to the relevant provisions of bioequivalence studies, ilaprazole enteric-coated tablets (specification: 5 mg, trade name: Yilian®) produced by the original manufacturer, Livzon Pharmaceutical Factory of Livzon Group, were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting conditions. Secondary objective: To observe the safety of the test preparation ilaprazole enteric-coated tablets and the reference preparation ilaprazole enteric-coated tablets (Yilian®) in healthy subjects.