Zhejiang Huayi Pharmaceutical Co. Ltd.

Primary objective: To evaluate the bioequivalence of the test preparation (vonoprazan fumarate tablets declared by Zhejiang Huayi Pharmaceutical Co., Ltd., specification: 20 mg) and the reference preparation (vonoprazan fumarate tablets certified by Takeda Pharmaceutical Company Limited, specification 20 mg, trade name: Vocinti) in Chinese healthy subjects under fasting and fed conditions, using the main pharmacokinetic parameters (AUC and Cmax) of vonoprazan as the evaluation indicators of bioequivalence. Secondary objective: To observe the safety of the test preparation and the reference preparation under fasting and fed conditions.

Primary objective: To evaluate the bioequivalence of the test formulation (ibrutinib capsules produced by Zhejiang Huayi Pharmaceutical Co., Ltd., Hangzhou Huadong Medicine Group, specification 140 mg) and the reference formulation (ibrutinib capsules produced by Catalent CTS LLC, specification 140 mg, trade name: Imbruvica®/Yike®) in healthy Chinese subjects under fasting and fed conditions, using the main pharmacokinetic parameters (AUC and Cmax) of ibrutinib as the evaluation indicators of bioequivalence. Secondary objective: To observe the safety of oral administration of the test formulation and the reference formulation under fasting and fed conditions.

Main study objectives: 1 To quantitatively analyze the total radioactivity in excreta after oral administration of [14C]bangretinib to healthy male subjects, and obtain the cumulative excretion rate and main excretion pathway of human radioactivity; 2 To investigate the distribution of [14C]bangretinib in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral administration of [14C]bangretinib to healthy male subjects; 3 To identify the main metabolites in plasma, urine and feces after oral administration of [14C]bangretinib to healthy male subjects, and determine the main biotransformation pathways and main metabolites (close to or greater than 10% of the total radioactivity AUC); 4 To quantitatively analyze the concentration of bangretinib and its main metabolites (if applicable) in plasma using a validated LC-MS/MS method, and obtain the pharmacokinetic parameters of bangretinib and its main metabolites (if applicable) in plasma. Secondary study objectives: To observe the safety of healthy male subjects after a single dose of [14C]bangretinib.