Fujian Haixi New Drug Creation Co., Ltd.

This study aimed to investigate the pharmacokinetic characteristics of a single-dose, fasting oral administration of bismuth potassium citrate tablets [120 mg (based on Bi2O3)] developed and manufactured by Fujian Haixi New Drug Innovation Co., Ltd. A reference formulation was used, with bismuth potassium citrate tablets [Gastrodenol®, 120 mg (based on Bi2O3)] manufactured by Industria Química y Farmacéutica VIR, S.A. (licensed by Tora Laboratories S.L.). The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate the safety of the test formulation.

Primary Objective: This study used doxycycline hydrochloride tablets [0.1g (calculated as C22H24N2O8)] developed by Fujian Haixi New Drug Innovation Co., Ltd. as the test formulation, and, in accordance with relevant regulations for bioequivalence studies, used doxycycline hydrochloride tablets [0.1g (calculated as C22H24N2O8), trade name: Vibramycin®] certified by Pfizer Japan Inc. as the reference formulation, to evaluate the bioequivalence of the test and reference formulations under fasting/postprandial administration conditions. Secondary Objective: To observe the safety of the test and reference formulations, doxycycline hydrochloride tablets (Vibramycin®), in healthy subjects.

Primary objective: This study used tizanidine hydrochloride tablets [specification: 2 mg (C9H8ClN5S)] developed by Fujian Haixi New Drug Innovation Co., Ltd. as the test formulation, and, in accordance with relevant regulations for bioequivalence studies, used tizanidine hydrochloride tablets [specification: 2 mg (C9H8ClN5S), trade name: Sirdalud], owned by Sandoz S.p.A. and manufactured by Novartis Farma S.p.A., as the reference formulation, to evaluate the bioequivalence of the test and reference formulations under fasting/postprandial administration conditions. Secondary objective: To observe the safety of the test and reference formulations, tizanidine hydrochloride tablets (trade name: Sirdalud), in healthy trial participants.