Shandong Haiya Medical Technology Co., Ltd.

To explore the efficacy and safety of HY-0902 tablets in the treatment of patients with gout and hyperuricemia; to evaluate the pharmacokinetic (PK) characteristics of HY-0902 tablets in patients with gout and hyperuricemia; to explore the population pharmacokinetic (CPopPK) characteristics and exposure-effect relationship of HY-0902 in patients with gout and hyperuricemia.

Primary purpose: To evaluate the safety and tolerability of HY-0902 tablets after single and multiple oral administration in healthy subjects. Secondary purpose: To evaluate the pharmacokinetic characteristics of HY-0902 tablets after single and multiple oral administration in healthy subjects; to evaluate the effect of food on the pharmacokinetics of HY-0902 tablets and the safety and tolerability of oral administration of HY-0902 tablets in the postprandial state.

Healthy Chinese subjects were used as test subjects. A self-cross-controlled experimental design was adopted to determine the time course of plasma concentration of vardenafil hydrochloride in healthy subjects after oral administration of vardenafil hydrochloride tablets licensed by Shandong Haiya Pharmaceutical Technology Co., Ltd. and produced by Nanjing Haina Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Vardenafil hydrochloride tablets [trade name: Aili Da®] licensed by Bayer AG were used as reference to investigate the bioavailability of the test preparation, evaluate the bioequivalence between preparations, and observe the safety of vardenafil hydrochloride tablets in healthy Chinese subjects.