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Clinical Trials associated with RF-16001注射用罗哌卡因缓释微球在健康志愿者中的药代动力学对比研究
[Translation] Comparative study on the pharmacokinetics of ropivacaine sustained-release microspheres for injection in healthy volunteers
研究目的:
主要目的:考察在健康志愿者中,单次皮下多点注射新、旧2个场地生产的注射用罗哌卡因缓释微球(制剂T和制剂R)425 mg的药代动力学(PK)特征,并评价两制剂的PK差异;
次要目的:评价在健康志愿者中,单次皮下多点注射新场地生产的注射用罗哌卡因缓释微球425 mg的安全性和耐受性。
[Translation] Study objectives:
Primary objective: To investigate the pharmacokinetic (PK) characteristics of ropivacaine sustained-release microspheres (formulations T and R) produced at two new and old sites in healthy volunteers after a single subcutaneous multiple-point injection of 425 mg, and to evaluate the PK differences between the two preparations;
Secondary objective: To evaluate the safety and tolerability of ropivacaine sustained-release microspheres produced at the new site in healthy volunteers after a single subcutaneous multiple-point injection of 425 mg.
100 Clinical Results associated with RF-16001
100 Translational Medicine associated with RF-16001
100 Patents (Medical) associated with RF-16001
100 Deals associated with RF-16001