Shanghai Fudan Forward Pharmaceutical Co. Ltd.

This study aimed to investigate the pharmacokinetic characteristics of brepirazole tablets (2 mg) developed and produced by Shanghai Fudan Fuhua Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Using brepirazole tablets (Rexulti®, 2 mg) produced by Otsuka Pharmaceutical Co., Ltd. as the reference preparation, the pharmacokinetic parameters Cmax and AUC0-72 of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.

The main purpose of the study was to use tamoxifen citrate tablets (10 mg) developed by Shanghai Fudan Fuhua Pharmaceutical Co., Ltd. as the test preparation. According to the relevant provisions of the bioequivalence study, the relative bioavailability in healthy humans was compared with that of tamoxifen citrate tablets (reference preparation, trade name: Nolvadex®, specification: 10 mg) certified by Astrazeneca K.K., and to investigate the human bioequivalence of the two preparations. Secondary purpose of the study was to observe the safety of the test preparation (specification: 10 mg) and the reference preparation (trade name: Nolvadex®, specification: 10 mg) of tamoxifen citrate tablets in healthy subjects.

Preliminary test Investigate the PK parameters of lacosamide tablets under fasting conditions, verify the rationality of the blood drug concentration analysis method and the blood collection time, sampling volume, time interval, etc., estimate the intra-individual coefficient of variation, and preliminarily evaluate the bioequivalence of the two preparations. Formal test Investigate the PK parameters and BA of the test preparation and the reference preparation in the fasting and postprandial state of single administration, and evaluate whether the two preparations are equivalent. At the same time, evaluate the safety and tolerability of the two preparations in healthy humans.