PKU HealthCare Corp., Ltd.

The relative bioavailability of the test preparation lurasidone hydrochloride tablets [Specification: 40 mg (calculated as C28H36N4O2S·HCl)] and the reference preparation [trade name: Lurasida®, specification: 40 mg (calculated as C28H36N4O2S·HCl)] in healthy Chinese subjects after a single oral administration (fasting/postprandial) was investigated, the pharmacokinetic parameters of the two preparations were analyzed, and the bioequivalence of the two preparations was evaluated, so as to provide a reference for the application and clinical use of the drug.

This study aimed to investigate the pharmacokinetic characteristics of single fasting and postprandial oral administration of finerenone tablets (10 mg) developed and produced by Peking University Pharmaceutical Co., Ltd. in healthy study participants; finerenone tablets (Cosenta®, 10 mg) produced by Bayer AG were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared.

This study aimed to investigate the pharmacokinetic characteristics of isavuconazole sulfate capsules (100 mg) developed and produced by Peking University Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Isavuconazole sulfate capsules (Kangxinbo®, 100 mg) licensed by Pfizer Australia Pty Ltd were used as the reference preparation. The pharmacokinetic parameters Cmax and AUC0-72 of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.