Shandong Lukang Pharmaceutical Group Saite Co., Ltd.

This study aimed to investigate the pharmacokinetic characteristics of doxazosin mesylate extended-release tablets [4 mg (calculated as doxazosin)], certified by Shandong Lukang Pharmaceutical Group Saite Co., Ltd., after a single fasting and postprandial oral administration in healthy study participants. Doxazosin mesylate extended-release tablets [Kadohua®, 4 mg (calculated as doxazosin)], certified by Viatris Pharmaceuticals LLC, were used as the reference formulation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their human bioequivalence and to observe their safety in healthy study participants.

Primary objective: To investigate the relative bioavailability of a single oral dose of dapagliflozin tablets 10 mg (test formulation) manufactured by Shandong Lukang Pharmaceutical Group Co., Ltd., and the original dapagliflozin tablets 10 mg (FORXIGA®/Andatang®, reference formulation) manufactured by AstraZeneca (AstraZeneca AB), in healthy subjects under fasting conditions, and to evaluate the bioequivalence between the test and reference formulations. Secondary objective: To observe the safety and tolerability of the test and reference formulations in healthy Chinese subjects by monitoring changes in adverse event rates, laboratory test results, vital signs, and physical examination findings.

Primary objective: To evaluate the bioequivalence of azithromycin dry suspension (trade name: Zithromax®) manufactured by Shandong Lukang Pharmaceutical Group Co., Ltd. as the test formulation after a single oral administration under fasting conditions in Chinese healthy participants. This study used azithromycin dry suspension manufactured by Pfizer Pharmaceuticals Co., Ltd. as the reference formulation. Secondary objective: To evaluate the safety of the test and reference formulations in Chinese healthy participants.