[Translation] A Phase I clinical study of the safety, tolerability, pharmacokinetic characteristics, and food effects of GPN00204 in healthy adult subjects in China, using single and multiple oral administrations.
主要目的:评估 GPN00204 单、多次口服给药在中国健康成年受试者中的安全性和耐受性。
次要目的:评估 GPN00204 单、多次口服给药在中国健康成年受试者中的药代动力学(PK)特征,以及与桉柠蒎肠溶胶囊(切诺®,0.3g)单、多次口服给药后各成分的 PK 参数差异;评估食物对 GPN00204 药代动力学的影响。
[Translation] Primary objective: To evaluate the safety and tolerability of single and multiple oral doses of GPN00204 in healthy adult subjects in China.
Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of single and multiple oral doses of GPN00204 in healthy adult subjects in China, and to compare the PK parameters of each component with those of single and multiple oral doses of eucalyptol enteric-coated capsules (Cenox®, 0.3g); to evaluate the effect of food on the pharmacokinetics of GPN00204.