[Translation] A multicenter, randomized, open-label, single-dose, two-cycle, two-crossover bioequivalence study of irinotecan hydrochloride liposome injection in patients with advanced pancreatic cancer
主要目的:以Les Laboratoires Servier Industrie生产的盐酸伊立替康脂质体注射液(商品名:Onivyde®,规格:43 mg/10 mL)为参比制剂,以无锡济煜山禾药业股份有限公司生产的盐酸伊立替康脂质体注射液(规格:43 mg/10 mL)为受试制剂,进行体内药代动力学的对比研究,考察伊立替康脂质体在晚期胰腺癌患者体内的药代动力学行为,评价两种制剂的生物等效性。次要目的:评价受试制剂盐酸伊立替康脂质体注射液在晚期胰腺癌患者中的安全性。
[Translation] Primary objective: To compare the in vivo pharmacokinetics of irinotecan liposome injection (trade name: Onivyde®, specification: 43 mg/10 mL) produced by Les Laboratoires Servier Industrie as the reference preparation and irinotecan liposome injection (specification: 43 mg/10 mL) produced by Wuxi Jiyushanhe Pharmaceutical Co., Ltd. as the test preparation, to investigate the pharmacokinetic behavior of irinotecan liposome in patients with advanced pancreatic cancer and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation irinotecan liposome injection in patients with advanced pancreatic cancer.