Guangzhou Yudong Health Pharmaceutical Co., Ltd.

The study used healthy subjects as the test subjects, and adopted an open, randomized, two-period, double-crossover design to investigate the in vivo time course of upadacitinib after a single oral administration of upadacitinib sustained-release tablets (test preparation, specification: 15 mg) produced by Guangzhou Yudong Health Pharmaceutical Co., Ltd. and the reference preparation upadacitinib sustained-release tablets (trade name: RINVOQ, specification: 15 mg; owned by AbbVie Deutschland GmbH & Co. KG, produced by AbbVie lreland NLB.V) to healthy subjects on an empty stomach and after a meal, to estimate their relevant pharmacokinetic parameters and relative bioavailability, and to evaluate their bioequivalence in the empty stomach and after a meal state, so as to provide a basis for the production registration application of the test preparation.

Primary objective: To investigate the urinary potassium excretion and rate of potassium chloride sustained-release tablets (Klor-Con®, specification: 0.75 g/tablet) produced by Guangzhou Yudong Pharmaceutical Co., Ltd. or UPSHER-SMITH LABS after a single oral administration on an empty stomach in healthy subjects, to estimate their pharmacokinetic parameters, and to evaluate their relative bioavailability and bioequivalence in humans. Secondary objective: To investigate the safety and tolerability after oral administration.