Hunan Dongting Pharmaceutical Co., Ltd.

This study examined the oral administration of a single dose of alprazolam tablets (test preparation, specification: 0.4 mg) produced by Hunan Dongting Pharmaceutical Co., Ltd. or Alprazolam tablets produced by Biotech Co., Ltd. to healthy subjects under fasting and postprandial conditions. (Viatoris Pharmaceutical Co., Ltd.) Pharmacokinetic characteristics of certified alprazolam tablets (reference preparation, trade name: Solanax®, strength: 0.4 mg), to evaluate the bioequivalence and safety of the two preparations, which subject Provide a basis for consistency evaluation of trial preparations.

Primary objective: Using mirtazapine tablets (specification: 15 mg) provided by Hunan Dongting Pharmaceutical Co., Ltd. as the test preparation and mirtazapine tablets (specification: 15 mg, trade name: REMERON®) certified by ORGANON USA INC as the reference preparation, the pharmacokinetic differences between the test preparation and the reference preparation under fasting and postprandial administration conditions were compared to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy subjects.

A single-center, randomized, open, two-period, two-sequence, double-crossover, single-dose oral trial design was used to compare the differences in absorption extent and absorption rate between fluvoxamine maleate tablets (50 mg) produced by Hunan Dongting Pharmaceutical Co., Ltd. and fluvoxamine maleate tablets (50 mg, trade name: Luvox®/Lanshi®) certified by Abbott Laboratories (Singapore) Private Limited (Abbott) under fasting and fed dosing conditions in healthy Chinese people, and to evaluate the safety of fluvoxamine maleate tablets produced by Hunan Dongting Pharmaceutical Co., Ltd.