Shanxi BaoTai Pharmaceutical Co. Ltd.

Main study objectives Using vonoprazan fumarate tablets produced by Shanxi Baotai Pharmaceutical Co., Ltd. as the test preparation and vonoprazan fumarate tablets (trade name: Vocinti) certified by Takeda Pharmaceutical Company Limited as the reference preparation, a single-dose, randomized, open, two-period, double-crossover clinical study was conducted to evaluate the bioequivalence of the two preparations in the fasting or fed state. Secondary study objectives Observe the safety of the test preparation and the reference preparation in healthy adult subjects in China.

Primary objective: To investigate the pharmacokinetic parameters and relative bioavailability of domperidone tablets (test preparation, 10 mg/tablet) produced by Shanxi Baotai Pharmaceutical Co., Ltd. and Motilium (reference preparation, domperidone tablets, 10 mg/tablet) produced by Janssen-Cilag, France in healthy Chinese subjects, and to evaluate whether the two are bioequivalent after a single dose (fasting and postprandial). Secondary objective: To observe the safety of the test preparation and the reference preparation after administration in healthy subjects.

Mitiglinide calcium tablets (5 mg) produced by Hainan Rizhongtian Pharmaceutical Co., Ltd. were used as the test preparation. Human bioequivalence and bioavailability tests were conducted with mitiglinide calcium tablets produced by Japan Kisei Pharmaceutical Industry Co., Ltd., which are marketed in China, to compare the bioequivalence of the two preparations.