Harbin Medisan Pharmaceutical Co., Ltd.

Main objective: To investigate the in vivo time-dependent effects of a single-dose, randomized, open-label, two-formulation, two-sequence, two-period, double-crossover trial on merogalamine besylate tablets (test formulation, strength: 5 mg), manufactured by Harbin Sanlian Pharmaceutical Co., Ltd. and contracted by Lanxi Sanlian Pharmaceutical Co., Ltd., and merogalamine besylate tablets (reference formulation, trade name: Tarlige®, strength: 5 mg), manufactured by DAIICHI SANKYO CO., LTD. and TAIYO Pharma Tech CO., LTD., Takatsuki Plant, on merogalamine besylate after fasting and postprandial administration in healthy participants. The study aimed to estimate relevant pharmacokinetic parameters and relative bioavailability, evaluate bioequivalence under fasting and postprandial conditions, and provide a basis for the production registration application of the test formulation. Secondary objective: To evaluate the safety of the test and reference formulations of merogabarine besylate tablets (trade names: Tarlige®) in healthy trial participants.

Primary Objective: In accordance with relevant bioequivalence testing regulations, a bioequivalence study was conducted on the test formulation, flurbiprofen gel patch (trade name: Zepus®, specification: 40 mg flurbiprofen per patch (area 13.6 cm × 10.0 cm, paste weight 12 g) certified by Mikasa Seiyaku Co., Ltd., as the reference formulation. A fasting administration bioequivalence study was performed on the test formulation, flurbiprofen gel patch (specification: 40 mg flurbiprofen per patch (area 13.6 cm × 10.0 cm, paste weight 12 g) manufactured by Lanxi Ha Sanlian Pharmaceutical Co., Ltd. and provided by Harbin Sanlian Pharmaceutical Co., Ltd. The study aimed to compare whether the differences in the absorption rate and extent of the drug in the test formulation with those in the reference formulation were within acceptable ranges, and to evaluate the bioequivalence of the two formulations under fasting administration conditions. Secondary Objectives: 1. To observe the safety of topical application of the test formulation flurbiprofen gel patch and the reference formulation flurbiprofen gel patch in healthy subjects. 2. To assess the adhesion and topical irritation of the test formulation flurbiprofen gel patch and the reference formulation flurbiprofen gel patch to healthy volunteer subjects during the trial.

Primary Study Objective: In accordance with relevant bioequivalence testing regulations, asenapine maleate sublingual tablets (trade name: SAPHRIS®, strength: 5 mg) manufactured by Catalent UK Swindon Zydis Ltd. were selected as the reference formulation, and asenapine maleate sublingual tablets (strength: 5 mg) manufactured and provided by Harbin Sanlian Pharmaceutical Co., Ltd. were selected as the test formulation for a human bioequivalence study under fed administration conditions. The study aimed to compare the drug absorption rate and extent of the test formulation with those of the reference formulation to determine if they were within acceptable limits, and to evaluate the bioequivalence of the two formulations under fed administration conditions. Secondary Study Objective: To observe the safety of the test and reference formulations (trade name: SAPHRIS®, strength: 5 mg) and the reference formulation (trade name: SAPHRIS®, strength: 5 mg) after oral administration in healthy volunteers.