Jinan Gaohua Pharmaceutical Factory

Primary Objective: This study used febuxostat tablets (strength: 40 mg) manufactured by Jinan Gaohua Pharmaceutical Co., Ltd. as the test formulation and febuxostat tablets (trade name: FEBURIC; strength: 40 mg) manufactured by TEIJIN PHARMA LIMITED as the reference formulation to compare the bioequivalence of the test and reference formulations in healthy volunteers in the fed state. Secondary Objective: To observe the safety of the test and reference formulations in healthy volunteers.

Febuxostat tablets are an anti-gout drug, mainly used for the long-term treatment of hyperuricemia in gout patients. Elevated serum uric acid levels are the root cause of the occurrence and development of hyperuricemia, gout and their related complications. Febuxostat is a 2-arylthiazole derivative and a xanthine oxidase inhibitor, which can reduce serum uric acid concentration by inhibiting uric acid synthesis, thereby exerting its efficacy. Long-term standard serum uric acid levels can significantly reduce the frequency of gout attacks, prevent tophi formation, prevent bone destruction, reduce the risk of death and improve the quality of life of patients, which is the key to preventing gout and its related complications. Febuxostat tablets were developed by TEIJIN PHARMA LIMITED and were approved for marketing by the European Union on April 21, 2008. The current market specifications are 20mg, 40mg, 80mg and 120mg, and the domestic approved specifications are 20mg and 40mg respectively. In this study, febuxostat tablets (specification: 40 mg) produced by Jinan Gaohua Pharmaceutical Co., Ltd. were used as the test preparation, and febuxostat tablets (trade name: FEBURIC; specification: 40 mg) owned by the original developer TEIJIN PHARMA LIMITED were used as the reference preparation to compare the bioequivalence of the test preparation and the reference preparation in healthy subjects under fasting state.

Vonoprazan fumarate tablets (specification: 20 mg) provided by Jinan Gaohua Pharmaceutical Co., Ltd. were used as the test preparation, and Vonoprazan fumarate tablets (trade name: Vocinti (Walker); specification: 20 mg) certified by Takeda Pharmaceutical Company Limited were used as the reference preparation. The bioequivalence of the test preparation and the reference preparation under fasting and fed conditions was compared.