Ping Kuang Pharmaceutical Co., Ltd.

Main study objective: To investigate the pharmacokinetic characteristics of a single oral dose of fenelazol tablets (test formulation T, strength: 10 mg) provided by Pingguang Pharmaceutical Co., Ltd. and a single oral dose of fenelazol tablets (reference formulation R, trade name: Kerendia®, strength: 10 mg) certified by Bayer AG in healthy study participants after a meal, to compare the differences in pharmacokinetic parameters Cmax and AUC between the two formulations, and to preliminarily assess the bioequivalence of the two formulations.

This study investigated the pharmacokinetic characteristics of finerenone tablets (test formulation, strength: 10 mg) provided by Pingguang Pharmaceutical Co., Ltd. or finerenone tablets (reference formulation, trade name: Kerendia®, strength: 10 mg) certified by Bayer AG, after single oral administration under fasting and fed conditions in healthy study participants. The bioequivalence and safety of the two formulations were evaluated to provide a basis for the registration application of the test formulation.

Main study purpose: According to the relevant provisions of bioequivalence test, upadacitinib extended-release tablets (trade name: Ruifu®, specification: 15mg) of AbbVie Deutschland GmbH & Co. KG as the licensee were selected as the reference preparation, and the test preparation upadacitinib extended-release tablets (specification: 15mg) produced and provided by Pingguang Pharmaceutical Co., Ltd. were subjected to human bioequivalence test on fasting and postprandial administration, 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 study purpose: To observe the safety of oral administration of the test preparation upadacitinib extended-release tablets (specification: 15mg) and the reference preparation upadacitinib extended-release tablets (trade name: Ruifu®, specification: 15mg) by healthy volunteers.