[Translation] Phase I clinical trial of the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral administration of SP330 tablets in healthy subjects and the effect of food on the pharmacokinetics of SP330 tablets
主要目的:评价SP330片在健康受试者中单次、多次口服给药的安全性和耐受性、评价食物对SP330片药动学特征(PK)的影响;次要目的:评价SP330片在健康受试者单次、多次给药后的药代动力学(PK)及药效动力学(PD)特征、评价SP330片在健康受试者中空腹及进食高脂餐状态下的安全性 。
[Translation] The primary objective is to evaluate the safety and tolerability of single and multiple oral administration of SP330 tablets in healthy subjects, and to evaluate the effect of food on the pharmacokinetic characteristics (PK) of SP330 tablets. The secondary objective is to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of SP330 tablets after single and multiple administration in healthy subjects, and to evaluate the safety of SP330 tablets in healthy subjects in fasting and high-fat meal states.