[Translation] A single-center, randomized, double-blind, single and multiple-dose phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HEC93077 tablets in healthy subjects and patients with hyperuricemia
主要目的:评价HEC93077片在健康受试者和高尿酸血症患者中单次和多次口服给药的安全性和耐受性;
次要目的:评价HEC93077片在健康受试者和高尿酸血症患者中单次/多次给药的药代动力学(PK)特征;评价食物对HEC93077片药代动力学的影响;评价HEC93077片在人体内的药物代谢转化;评价HEC93077片在健康受试者和高尿酸血症患者中的药效学。
[Translation] Primary objective: To evaluate the safety and tolerability of single and multiple oral administration of HEC93077 tablets in healthy subjects and patients with hyperuricemia;
Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of single/multiple administration of HEC93077 tablets in healthy subjects and patients with hyperuricemia; To evaluate the effect of food on the pharmacokinetics of HEC93077 tablets; To evaluate the drug metabolism transformation of HEC93077 tablets in humans; To evaluate the pharmacodynamics of HEC93077 tablets in healthy subjects and patients with hyperuricemia.