[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalation safety, tolerability, and pharmacokinetic trial of single/multiple oral administration of HEC137076MsOH tablets and a single-center, randomized, double-blind, two-period, two-sequence crossover food effect trial in healthy Chinese subjects
主要目的: 评价HEC137076MsOH片在中国健康受试者中单次/多次口服给药的安全性和耐受性。
次要目的: 评价HEC137076MsOH片在中国健康受试者中单次/多次口服给药的药代动力学特征; 评价食物对HEC137076MsOH片药代动力学的影响; 评价HEC137076MsOH片在人体内的药物代谢转化。
[Translation] Primary objective: To evaluate the safety and tolerability of HEC137076MsOH tablets after single/multiple oral administration in healthy Chinese subjects.
Secondary objectives: To evaluate the pharmacokinetic characteristics of HEC137076MsOH tablets after single/multiple oral administration in healthy Chinese subjects; To evaluate the effect of food on the pharmacokinetics of HEC137076MsOH tablets; To evaluate the drug metabolism transformation of HEC137076MsOH tablets in humans.