[Translation] A randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability, and pharmacokinetics (PK) of pregabalin for injection in healthy adult volunteers
主要目的:1.观察健康成年志愿者注射用普瑞巴肽单剂的安全性和耐受性;2.研究健康成年志愿者注射用普瑞巴肽单剂的人体PK特征;探索性目的:1.观察健康成年志愿者注射用普瑞巴肽单剂对血小板聚集率的影响;2.观察健康成年志愿者注射用普瑞巴肽单剂对凝血功能的影响。
[Translation] Main objectives: 1. To observe the safety and tolerability of a single dose of pregibactide for injection in healthy adult volunteers; 2. To study the human PK characteristics of a single dose of pregibactide for injection in healthy adult volunteers; Exploratory objectives: 1. To observe the effect of a single dose of pregibactide for injection on platelet aggregation rate in healthy adult volunteers; 2. To observe the effect of a single dose of pregibactide for injection on coagulation function in healthy adult volunteers.