Suzhou Tianmayiyao Group Tianji Biology Pharmacy Co. Ltd.

This study investigated the pharmacokinetic characteristics of upadacitinib sustained-release tablets (test preparation, strength: 15 mg) provided by Jiangsu Pegasus Pharmaceutical Co., Ltd. and upadacitinib sustained-release tablets (reference preparation, trade name: Rinvoq®, strength: 15 mg) approved by AbbVie Deutschland GmbH & Co. KG in healthy male and female subjects under fasting and postprandial conditions, and evaluated the bioequivalence and safety of the two preparations to provide a basis for the registration application of the test preparation.

Primary objective: To evaluate the bioequivalence of the two preparations in Chinese healthy subjects in the fasting and postprandial states, using the brexiprazole tablets (trade name: Rexulti, specification: 2 mg) of the licensee Otsuka Pharmaceutical Co Ltd as the reference preparation and the brexiprazole tablets (specification: 2 mg) developed by Jiangsu Pegasus Pharmaceutical Co Ltd as the test preparation. Secondary objective: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.

To study the PK (Pharmacokinetics) behavior of meloxicam in healthy Chinese volunteers after a single oral administration of the test formulation of meloxicam tablets (Prilo®, 7.5 mg/tablet, Jiangsu Pegasus Pharmaceutical Co., Ltd.) and the reference formulation of meloxicam tablets (MOBEC®, 7.5 mg/tablet, Boehringer Ingelheim Pharma GmbH & Co.KG) on an empty stomach and after a meal, and to evaluate the bioequivalence of the two formulations after an empty stomach and after a meal. Secondary objective: To evaluate the safety of the test formulation and reference formulation of meloxicam tablets in healthy Chinese volunteers after a single oral administration.