Fujian Pinteng Pharmaceutical Co., Ltd.

To investigate the pharmacokinetic characteristics of a single oral administration of 1 tablet of vonoprazan fumarate tablets (test preparation, specification: 20 mg) provided by Fujian Pinteng Pharmaceutical Co., Ltd. and a single oral administration of 1 tablet of vonoprazan fumarate tablets (reference preparation, trade name: Walker®, specification: 20 mg) certified by Takeda Pharmaceutical Company Limited under fasting and postprandial conditions in healthy subjects, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.

Methods A single-center, randomized, open-label, three-period, partially repeated crossover, single-dose design was used to compare the differences in absorption extent and rate between diclofenac diethylamine emulsion [specification: 1% (20 g: 0.2 g), test preparation] provided by Fujian Pinteng Pharmaceutical Co., Ltd. and diclofenac diethylamine emulsion [trade name: Voltaren®, specification: 1% (20 g: 0.2 g), reference preparation] certified by GSK Consumer Healthcare Schweiz AG in healthy Chinese people under fasting conditions, to evaluate the bioequivalence of the two preparations when used in the fasting state, and to evaluate the safety of diclofenac diethylamine emulsion [specification: 1% (20 g: 0.2 g)] provided by Fujian Pinteng Pharmaceutical Co., Ltd.