[Translation] A phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and the effect of food on the pharmacokinetics of LM49 tablets in single and multiple escalating doses of oral LM49 tablets in healthy Chinese adult subjects
评估LM49片在中国健康受试者中单次和多次口服给药后的安全性和耐受性;
次要目的:
评估LM49片在中国健康受试者中单次和多次口服给药后的药代动力学(PK)特征;
评估LM49片在中国健康受试者中单次和多次口服给药后的药效动力学(PD)特征;
评估食物对LM49片在中国健康受试者中PK的影响;
血浆和尿液中代谢物鉴定及相对定量;
探索性目的:
初步评价LM49片在中国健康受试者单次和多次口服给药后的血药浓度与QTc间期的关系
[Translation] To evaluate the safety and tolerability of LM49 tablets after single and multiple oral administration in healthy Chinese subjects;
Secondary objectives:
To evaluate the pharmacokinetic (PK) characteristics of LM49 tablets after single and multiple oral administration in healthy Chinese subjects;
To evaluate the pharmacodynamic (PD) characteristics of LM49 tablets after single and multiple oral administration in healthy Chinese subjects;
To evaluate the effect of food on the PK of LM49 tablets in healthy Chinese subjects;
Identification and relative quantification of metabolites in plasma and urine;
Exploratory objectives:
To preliminarily evaluate the relationship between the blood drug concentration and QTc interval of LM49 tablets after single and multiple oral administration in healthy Chinese subjects