Henan Junshan Biotechnology Co., Ltd.

The main purpose of the study is to use the upadacitinib extended-release tablets (trade name: Rinvoq®) certified by AbbVie Deutschland GmbH & Co. KG as the reference preparation and the upadacitinib extended-release tablets produced by Henan Junshan Biotechnology 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.

Main purpose of the study: According to the provisions of the relevant bioequivalence test, Cefditoren Pivoxil Granules (Specification: 50mg (potency)/0.5g/bag) with Meiji Seika Pharma Co., Ltd. as the licensee was selected as the reference preparation, and the test preparation Cefditoren Pivoxil Granules (Specification: 50mg/0.5g) produced by Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. and licensed by Henan Junshan Biotechnology Co., Ltd. was subjected to human bioequivalence test under fasting and postprandial administration conditions, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary purpose of the study: To observe the safety of oral administration of the test preparation Cefditoren Pivoxil Granules (Specification: 50mg/0.5g) and the reference preparation Cefditoren Pivoxil Granules (Specification: 50mg (potency)/0.5g/bag) by healthy volunteers.

Primary objective: Using ezetimibe and rosuvastatin calcium tablets (trade name: Zenon Neo, specification: 10mg/10mg) from Sanofi-Aventis, S.R.O. as the reference preparation and ezetimibe and rosuvastatin calcium tablets (10mg/10mg) from Henan Junshan Biotechnology 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 fed states in healthy Chinese subjects. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.