Jincheng Haisi Pharmaceutical Co. Ltd.

The purpose of this study was to study the pharmacokinetic characteristics of a single fasting oral administration of rabeprazole sodium enteric-coated tablets (20 mg) developed and produced by Jincheng Haisi Pharmaceutical Co., Ltd.; using rabeprazole sodium enteric-coated tablets (Polite®, 20 mg) produced by Eisai (China) Pharmaceutical Co., Ltd. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.

The aim of this study was to investigate the pharmacokinetic characteristics of a single fasting and postprandial oral administration of rabeprazole sodium enteric-coated tablets (20 mg) developed and produced by Jincheng Haisi Pharmaceutical Co., Ltd.; using rabeprazole sodium enteric-coated tablets (Polite®, 20 mg) produced by Eisai (China) Pharmaceutical Co., Ltd. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.

This study adopted a randomized, open, single-dose, two-period, double-crossover design. The absorption rate and extent of the test formulation of olopatadine hydrochloride tablets (Jincheng Haisi Pharmaceutical Co., Ltd., 5 mg/tablet) or the reference formulation (5 mg/tablet, trade name: Allelock ®) were evaluated in healthy subjects under fasting and postprandial conditions, and the human bioequivalence of the two formulations was investigated. At the same time, the safety of olopatadine hydrochloride tablets in healthy people was observed.