Jiangsu Zhongbang Pharmaceutical Co. Ltd.

Methods: Healthy Chinese subjects were used as the subjects. A self-controlled crossover design was used to determine the time course of plasma concentrations of the active metabolite azilsartan in healthy subjects after administration of acesartan potassium tablets produced by Jiangsu Zhongbang Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Azilsartan potassium tablets (trade name: EDARBI®, strength: 80 mg based on acesartan (C30H24N4O8)) produced by Takeda Pharma A/S and Takeda Ireland Ltd. were used as the reference. Bioequivalence between the two preparations was evaluated, and the safety of acesartan potassium tablets in healthy Chinese subjects was observed.

Primary objective: To investigate the absorption rate and extent of the test preparation and the reference preparation under fasting and postprandial conditions after oral administration of a single dose of vonoprazan fumarate tablets (test preparation T, produced by Jiangsu Zhongbang Pharmaceutical Co., Ltd., specification: 20 mg) and vonoprazan fumarate tablets (reference preparation R, produced by Takeda Pharmaceutical Company Limited, Hikari Plant, trade name: Vocinti®, specification: 20 mg) to healthy subjects, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation vonoprazan fumarate tablets and the reference preparation vonoprazan fumarate tablets (Vocinti®) in healthy subjects.

Healthy Chinese subjects were used as test subjects. A self-crossover design was used to determine the time course of telmisartan concentration in plasma after administration of telmisartan tablets produced by Jiangsu Zhongbang Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Telmisartan tablets [trade name: Micardis®] produced by Boehringer Ingelheim Ellas A.E. under the license of Boehringer Ingelheim International GmbH were used as reference to evaluate the bioequivalence between the preparations and to observe the safety of telmisartan tablets in healthy Chinese subjects.