Zhejiang Garden Pharmaceutical Co., Ltd.

The ezetimibe atorvastatin calcium tablets (II) (specification: 10 mg/20 mg) owned by Zhejiang Huayuan Pharmaceutical Co., Ltd. were used as the test preparation, and the ezetimibe atorvastatin calcium tablets (ATOZET®, specification: 10 mg/20 mg) marketed by Organon Healthcare GmbH were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

The main purpose of the study is to use the upadacitinib extended-release tablets (trade name: Rinvoq (瑞福)) certified by AbbVie Deutschland GmbH & Co. KG as the reference preparation and the upadacitinib extended-release tablets produced by Zhejiang Huayuan Pharmaceutical Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations in the fasting and fed state through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

The test preparation was ezetimibe atorvastatin calcium tablets (specification: 10 mg/10 mg) owned by Zhejiang Huayuan Pharmaceutical Co., Ltd., and the reference preparation was ezetimibe atorvastatin calcium tablets (ATOZET®, specification: 10 mg/10 mg) marketed by Merck Sharp & Dohme. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.