Zhuhai Tongyuan Pharmaceutical Co. Ltd.

Main purpose: With healthy subjects as the test subjects, an open, randomized, two-period, double-crossover design was used to investigate the in vivo time course of melogabalin after a single oral administration of melogabalin besylate tablets (test preparation, specification: 5 mg) produced by Guangzhou Yudong Health Pharmaceutical Co., Ltd. owned by Zhuhai Tongyuan Pharmaceutical Co., Ltd. and melogabalin besylate tablets (reference preparation, TARLIGE ®, specification: 5 mg) produced by Daiichi Sankyo Co., Ltd., to estimate their relevant pharmacokinetic parameters and relative bioavailability, evaluate their bioequivalence in the postprandial state, and provide a basis for the production registration application of the test preparation. Secondary purpose: To evaluate the safety of the test preparation and reference preparation of melogabalin besylate tablets (trade name: TARLIGE®) in healthy subjects.

Main purpose: With healthy subjects as the test subjects, an open, randomized, two-period, double-crossover design was used to investigate the in vivo time course of melogabalin after a single oral administration of melogabalin besylate tablets (test preparation, specification: 5 mg) produced by Guangzhou Yudong Health Pharmaceutical Co., Ltd. owned by Zhuhai Tongyuan Pharmaceutical Co., Ltd. and melogabalin besylate tablets (reference preparation, TARLIGE ®, specification: 5 mg) produced by Daiichi Sankyo Co., Ltd. on an empty stomach, to estimate their relevant pharmacokinetic parameters and relative bioavailability, to evaluate their bioequivalence under fasting conditions, and to provide a basis for the production registration application of the test preparation. Secondary purpose: To evaluate the safety of the test preparation and reference preparation of melogabalin besylate tablets (trade name: TARLIGE®) in healthy subjects.

Main objective: Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation olopatadine hydrochloride granules (specification: 2.5 mg (0.5 g/bag), license holder: Zhuhai Tongyuan Pharmaceutical Co., Ltd.) and the reference preparation olopatadine hydrochloride granules (specification: 0.5% (0.5 g/bag), license holder: Kyowa Kirin Co., Ltd., trade name: Allelock®) in healthy Chinese subjects after oral administration in the fasting/postprandial state was compared, and the bioequivalence of the test preparation and the reference preparation was evaluated. Secondary objective: To observe the safety of the test preparation, Olopatadine Hydrochloride Granules, and the reference preparation, Olopatadine Hydrochloride Granules in healthy Chinese subjects.