Yunnan Xianshi Pharmaceutical Co., Ltd.

This study aimed to investigate the pharmacokinetic characteristics of a single fasting and postprandial oral administration of quetiapine fumarate sustained-release tablets (200 mg) developed by Yunnan Xianshi Pharmaceutical Co., Ltd. and produced by Shandong Yaoshi Pharmaceutical Co., Ltd.; using quetiapine fumarate sustained-release tablets (200 mg) produced by AstraZeneca Pharmaceuticals LP as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.

Main study objectives To study the pharmacokinetic characteristics of a single oral administration of tofacitinib citrate sustained-release tablets (test preparation, specification: 11 mg) provided by Yunnan Xianshi Pharmaceutical Co., Ltd. (produced by Sichuan Kelun Pharmaceutical Co., Ltd.) and a single oral administration of tofacitinib citrate sustained-release tablets (reference preparation, trade name: XELJANZ®XR, specification: 11 mg) certified by Pfizer Inc. under the same conditions, to evaluate the bioequivalence between the two preparations and provide a basis for the registration application of the test preparation. Secondary study objectives To observe the safety of a single oral administration of 1 tablet of the test preparation tofacitinib citrate sustained-release tablets (specification: 11 mg) and 1 tablet of the reference preparation tofacitinib citrate sustained-release tablets (trade name: XELJANZ®XR, specification: 11 mg) in healthy subjects under fasting and postprandial conditions.

Primary objective: Using Avatrombopag Maleate Tablets (trade name: Doptelet (Su Kexin), specification: 20 mg (calculated in C29H34Cl2N6O3S2)) from AkaRx, Inc as the reference preparation and Avatrombopag Maleate Tablets (20 mg (calculated in C29H34Cl2N6O3S2)) developed by Yunnan Xianshi Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-preparation, two-sequence, four-period, completely repeated crossover design clinical trial was conducted to evaluate the bioequivalence of the two preparations in fasting and postprandial states in healthy Chinese subjects. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.