[Translation] A single oral, dose-escalating, single-center, randomized, double-blind, placebo-controlled safety, tolerability, and pharmacokinetics study of LV232 capsules in healthy Chinese subjects
主要目的:
评估LV232胶囊单次给药后的耐受性和安全性;
评估LV232胶囊单次给药的安全剂量范围;
评估LV232胶囊单次给药的药代动力学特征。
次要目的:
鉴定健康受试者口服LV232胶囊后的代谢产物结构并初步评价LV232的物质平衡。
探索性目的:
探索药物代谢酶的基因多态性对药物药代动力学及安全性的影响。
[Translation] Primary objectives:
Evaluate the tolerability and safety of LV232 capsules after a single dose;
Evaluate the safe dose range of LV232 capsules after a single dose;
Evaluate the pharmacokinetic characteristics of LV232 capsules after a single dose.
Secondary objectives:
Identify the metabolite structure after oral administration of LV232 capsules to healthy subjects and preliminarily evaluate the material balance of LV232.
Exploratory objectives:
Explore the effect of genetic polymorphisms of drug-metabolizing enzymes on drug pharmacokinetics and safety.