Jiangsu Fudan Fuhua Pharmaceutical Co., Ltd.

To investigate whether there are differences in the extent and rate of absorption between the test formulation, safinamide mesylate tablets (Jiangsu Fudan Fuhua Pharmaceutical Co., Ltd., strength: 100 mg) and the reference formulation, safinamide mesylate tablets (trade name: Xadago®; licensed by Zambon S.p.A., strength: 100 mg), after single oral administration on an empty stomach or after a meal in healthy participants, to evaluate the bioequivalence of the test formulation and the reference formulation when administered on an empty stomach or after a meal, and to observe the safety of the test formulation and the reference formulation in healthy participants.

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.