(S)-Oxiracetam

Primary objectives (1) To evaluate the safety and tolerability of (S)-Oxiracetam capsules after single and multiple oral administration in healthy Chinese subjects. (2) To evaluate the pharmacokinetic characteristics of (S)-Oxiracetam capsules after single and multiple oral administration in healthy Chinese subjects. Secondary objectives (1) To evaluate the chiral transformation of (S)-Oxiracetam capsules in healthy Chinese subjects. (2) To evaluate the effect of food on the absorption of (S)-Oxiracetam capsules. (3) To explore the metabolite profile of (S)-Oxiracetam capsules in healthy Chinese subjects.

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.