Shanghai Shangyao Chinese-Western Pharmaceutical Co., Ltd

This study investigated the pharmacokinetic characteristics of ondansetron orodispersible film (test preparation, specification: 8 mg/tablet) provided by Shanghai SPH Sino-Western Pharmaceutical Co., Ltd. and ondansetron orodispersible film (reference preparation, trade name: Setofilm®, specification: 8 mg/tablet) approved by Norgine Pharmaceuticals Limited in healthy subjects under fasting and postprandial conditions, and evaluated the bioequivalence and safety of the two preparations to provide a basis for the registration application of the test preparation.

Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behaviors of the test formulation of tofacitinib citrate extended-release tablets and the reference formulation in healthy subjects after oral administration in the fasting/postprandial state were compared to evaluate the bioequivalence of the two formulations.

Ia: Linear kinetics and bioavailability study of rasagiline sublingual film in healthy subjects Main purpose: To investigate the linear kinetics and bioavailability of 0.25, 0.5, and 1.0 mg of rasagiline mesylate sublingual film and rasagiline mesylate tablets (Azilect) certified by Teva Neuroscience Inc. in healthy subjects. Dose adjustment optimization was performed by comparing with the original Azilect. Secondary purpose: To observe the safety of rasagiline mesylate sublingual film after a single administration in healthy subjects. To evaluate the dynamic change characteristics after sublingual film administration and the subjects' medication experience. Ib: Bioavailability study Main purpose: To investigate the pharmacokinetic characteristics of a single oral administration of rasagiline mesylate sublingual film (test preparation, specification: adjusted according to the results of the Phase Ia trial) developed by Shanghai Shangyao Zhongxi Pharmaceutical Co., Ltd. and rasagiline mesylate tablets (reference preparation, trade name: Azilect ®, specification: 1 mg) certified by Teva Neuroscience Inc under standard meal conditions, and to evaluate the bioavailability and differences between the two preparations. Secondary purpose: To observe the safety of rasagiline mesylate sublingual film after a single administration in healthy subjects. To evaluate the medication experience of subjects who received sublingual film administration.