[Translation] A study to evaluate the safety, tolerability, pharmacokinetics and food effects of HPN-01 enteric-coated capsules in Chinese healthy subjects in a single-center, randomized, double-blind, single- and multiple-dosing dose-escalation Phase I clinical study
主要目的:
考察健康受试者单、多次口服给予HPN-01肠溶胶囊的安全性和耐受性;
次要目的:
评价健康受试者单、多次口服给予HPN-01肠溶胶囊的药代动力学特性;
评价食物对健康受试者单次服用HPN-01肠溶胶囊后药代动力学特性的影响;
[Translation] main purpose:
To investigate the safety and tolerability of single or multiple oral administration of HPN-01 enteric-coated capsules to healthy subjects;
Secondary purpose:
To evaluate the pharmacokinetic properties of single and multiple oral administration of HPN-01 enteric-coated capsules to healthy subjects;
To evaluate the effect of food on the pharmacokinetics of healthy subjects after a single dose of HPN-01 enteric-coated capsules;