[Translation] A randomized, open-label, two-period, two-crossover bioequivalence trial of irinotecan liposome injection in patients with advanced pancreatic cancer
主要研究目的:研究单次给予受试制剂伊立替康脂质体注射液(规格:43 mg/10 mL,浙江海昶生物医药技术有限公司委托东营天东制药有限公司生产)与参比制剂伊立替康脂质体注射液(商品名:ONIVYDE®,规格:43 mg/10 mL;Les Laboratoires Servier持证,Les Laboratoires Servier Industrie生产)在晚期胰腺癌患者体内的药代动力学,评价两种制剂的生物等效性。次要研究目的:研究受试制剂伊立替康脂质体注射液43 mg/10 mL和参比制剂伊立替康脂质体注射液(商品名:ONIVYDE®)43 mg/10 mL在晚期胰腺癌患者中的安全性。
[Translation] The main research purpose: To study the single administration of the test preparation irinotecan liposome injection (specification: 43 mg/10 mL, produced by Dongying Tiandong Pharmaceutical Co., Ltd. entrusted by Zhejiang Haichang Biomedical Technology Co., Ltd.) The pharmacokinetics of Rinotecan liposome injection (trade name: ONIVYDE®, specification: 43 mg/10 mL; licensed by Les Laboratoires Servier, produced by Les Laboratoires Servier Industrie) in patients with advanced pancreatic cancer, evaluating two formulations bioequivalence. Secondary research purpose: To study the effect of the test preparation irinotecan liposome injection 43 mg/10 mL and the reference preparation irinotecan liposome injection (trade name: ONIVYDE®) 43 mg/10 mL on the efficacy of advanced pancreatic cancer safety in patients.