Cisen Pharmaceutical Ltd.

Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation fenelazol tablets (10 mg, manufactured by Chenxin Pharmaceutical Co., Ltd.) and the reference formulation fenelazol tablets (Kerendia®, 10 mg, Bayer AG certified) in healthy adult participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions. Secondary objective: To assess the safety of the test formulation fenelazol tablets (10 mg) and the reference formulation fenelazol tablets (Kerendia®, 10 mg) in healthy adult participants.

Primary objective: To investigate the pharmacokinetic characteristics of a single oral dose of the test formulation linagliptin tablets (5 mg, certified by Chenxin Pharmaceutical Co., Ltd.) and the reference formulation linagliptin tablets (Otangnin®, 5 mg, certified by Boehringer Ingelheim International GmbH) in healthy adult participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions. Secondary objective: To assess the safety of the test formulation linagliptin tablets (5 mg) and the reference formulation linagliptin tablets (Otangnin®, 5 mg) in healthy participants.

Primary Objectives: 1) To quantitatively analyze the total radioactivity in urine and feces of healthy trial participants after a single oral administration of [14C]WXSH0102, obtaining the radioactivity recovery rate and main excretion pathways in human excrement. 2) To quantitatively analyze the radiometabolite profile in human plasma of healthy trial participants after a single oral administration of [14C]WXSH0102, identifying the main circulating metabolites in plasma (approximately or greater than 5% of the total radioactivity AUC). 3) To quantitatively analyze the radiometabolite profile in urine and feces of healthy trial participants after a single oral administration of [14C]WXSH0102, identifying the main metabolites in excrement, and determining the main metabolic and elimination pathways of WXSH0102 in the human body. Secondary Objectives: 1) To quantitatively analyze the total radioactivity in whole blood and plasma of healthy trial participants after a single oral administration of [14C]WXSH0102, obtaining the pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable), and investigating the distribution of total radioactivity in whole blood and plasma. 2) The concentrations of WXSH0102, the active metabolite WXFL20310031, and other metabolites (if applicable) in plasma of healthy participants after a single oral administration of [14C]WXSH0102 were quantitatively analyzed using a validated LC-MS/MS method to evaluate the corresponding pharmacokinetic parameters in plasma. 3) The safety of participants after a single dose of [14C]WXSH0102 was evaluated.