Chongqing Qingyutang Pharmaceutical Co. Ltd.

Primary Study Objective: To assess the bioequivalence of a single oral dose of the test formulation (5 mg, manufactured by Qingyutang Pharmaceutical Co., Ltd., Fu'an Pharmaceutical Group) and the reference formulation (trade name: DAYVIGO®, 5 mg, licensed by Aezai Co., Ltd.) of Leborexen tablets in healthy subjects after a meal. Secondary Study Objective: To observe the safety of the test and reference formulations of Leborexen tablets in healthy subjects.

Primary Study Objective: A bioequivalence study was conducted using cefuroxime axetil dry suspension (125 mg) produced by Qingyutang Pharmaceutical Co., Ltd. of Fu'an Pharmaceutical Group as the test formulation (T) and cefuroxime axetil dry suspension (125 mg/5 mL, trade name: Zinnat®) produced by Glaxo Operations UK Ltd as the reference formulation (R), in accordance with relevant bioequivalence testing regulations. Secondary Study Objective: To observe the safety of the test and reference formulations in healthy volunteers.

Main study objectives To investigate the bioequivalence of the test formulation of Lebrexan tablets (5 mg, produced by Qingyutang Pharmaceutical Co., Ltd., Fu'an Pharmaceutical Group) and the reference formulation (trade name: DAYVIGO®, 5 mg, certified by AEISHI Co., Ltd.) after a single oral administration in healthy subjects under fasting state. Secondary study objectives To observe the safety of the test formulation and the reference formulation of Lebrexan tablets in healthy subjects.