Shanghai Fudan Forward Pharmaceutical Co. Ltd.

Primary objective: To evaluate the bioequivalence of merogalaline besylate tablets (licensed by Shanghai Fudan Fuhua Pharmaceutical Co., Ltd.) under fasting and postprandial conditions in a single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover clinical trial, using merogalaline besylate tablets (trade name: Delijing®, strength: 5 mg (C12H19NO2)) licensed by DAIICHI SANKYO CO., LTD. Secondary objective: To observe the safety of the test and reference formulations in healthy Chinese participants.

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.

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.