[Translation] A phase I clinical trial to evaluate the tolerability, safety, and pharmacokinetic characteristics of single and multiple oral administration of QR059349 tablets in healthy Chinese adult volunteers and the effect of food on the pharmacokinetics of QR059349 tablets
主要目的:评估中国健康志愿者单、多次口服QR059349片后的安全性、耐受性;
次要目的:评估中国健康志愿者单、多次口服QR059349片后的药代动力学(Pharmacokinetics, PK)特征及食物对QR059349片PK特征的影响;
探索性目的:初步开展人体中药物代谢产物探索性研究;探索QR059349片药效动力学(Pharmacodynamics, PD)相关标志物水平及其与PK参数的关系。
[Translation] Primary purpose: To evaluate the safety and tolerability of QR059349 tablets after single and multiple oral administration in healthy Chinese volunteers;
Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of QR059349 tablets after single and multiple oral administration in healthy Chinese volunteers and the effect of food on the PK characteristics of QR059349 tablets;
Exploratory purpose: To conduct preliminary exploratory studies on drug metabolites in humans; to explore the levels of pharmacodynamic (PD)-related markers of QR059349 tablets and their relationship with PK parameters.