Hainan Rizhongtian Pharmaceutical Co., Ltd.

Primary objective: To investigate the pharmacokinetic characteristics of a single oral dose of risperidone tablets (test formulation, strength: 1 mg) provided by Hainan Rizhongtian Pharmaceutical Co., Ltd., and a single oral dose of risperidone tablets (reference formulation, trade name: Risperidone®, strength: 1 mg) certified by Xian Janssen Pharmaceutical Co., Ltd., under the same fasting conditions in healthy trial participants, to evaluate the bioequivalence of the two formulations, and to provide a basis for the registration application of the test formulation. Secondary objective: To observe the safety of a single oral dose of the test formulation or the reference formulation in healthy trial participants.

This study aimed to investigate the pharmacokinetic characteristics of cefpodoxime proxetil dry suspension (50 mg) developed and produced by Hainan Rizhongtian Pharmaceutical Co., Ltd., administered orally on an empty stomach and after a meal. Cefpodoxime proxetil dry syrup (BANAN®, 50 mg/g) produced by Daiichi Sankyo Co., Ltd. was used as a reference formulation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their bioequivalence in humans.

This study aimed to investigate the pharmacokinetic characteristics of aripiprazole tablets (10 mg) developed and produced by Hainan Rizhongtian Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using aripiprazole tablets (10 mg) licensed and produced by Zhejiang Otsuka Pharmaceutical Co., Ltd. as the reference preparation, the pharmacokinetic parameters Cmax and AUC0-72 of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.