[Translation] Single and multiple dose safety, tolerability, pharmacokinetic studies, and comparative pharmacokinetic studies in healthy Chinese subjects
1.以中国健康受试者为对象,安慰剂对照,剂量递增研究,考察左旋奥拉西坦注射液在人体内单次和多次给药的安全剂量范围,确定单次和多次用药的最大耐受量以及药代动力学特征,为II期临床试验给药方案提供依据。2.单词给药左旋奥拉西坦和奥拉西坦注射液,确定并比较两制剂的安全性、有效性及是否有体内变化。
[Translation] 1. A placebo-controlled, dose-escalation study was conducted on healthy Chinese subjects to investigate the safe dosage range of single and multiple administrations of levo-oxiracetam injection in humans, determine the maximum tolerated dose and pharmacokinetic characteristics of single and multiple administrations, and provide a basis for the dosing regimen of Phase II clinical trials. 2. Single-dose administration of levo-oxiracetam and oxiracetam injection was performed to determine and compare the safety, efficacy, and in vivo changes of the two preparations.