[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study of bupivacaine liposome injection in healthy adult participants under fasting condition
主要试验目的:研究空腹状态下单次皮下浸润注射受试制剂布比卡因脂质体注射液[规格:20 ml: 266 mg (13.3 mg/ml)], 浙江昂利康制药股份有限公司生产与参比制剂布比卡因脂质体注射液(Exparel®规格: 266 mg/20ml (13.3 mg/ml): Pacira Pharmaceuticals, Inc. 持证)在健康参与者体内的药代动力学特征,评价空腹状态单次给药后两种制剂的生物等效性。次要试验目的:研究受试制剂布比卡因脂质体注射液(规格: 20 ml:266 mg (13 .3 mg/ml) ) 和参比制剂布比卡因脂质体注射液(Expare®) ( 规格: 266 mg/20 ml (13.3 mg/ml) ) 在健康参与者中的安全性。
[Translation] Primary study objective: To investigate the pharmacokinetic characteristics of a single subcutaneous infiltration injection of the test preparation bupivacaine liposome injection [Specification: 20 ml: 266 mg (13.3 mg/ml)], produced by Zhejiang Anlikang Pharmaceutical Co., Ltd. and the reference preparation bupivacaine liposome injection (Exparel® Specification: 266 mg/20ml (13.3 mg/ml): Pacira Pharmaceuticals, Inc.) in healthy participants under fasting conditions, and to evaluate the bioequivalence of the two preparations after a single dose in the fasting state. Secondary study objective: To investigate the safety of the test preparation bupivacaine liposome injection (Specification: 20 ml:266 mg (13 .3 mg/ml)) and the reference preparation bupivacaine liposome injection (Expare®) (Specification: 266 mg/20 ml (13.3 mg/ml)) in healthy participants.