[Translation] A multicenter, randomized, open-label, single-dose, two-cycle, two-crossover bioequivalence study of irinotecan hydrochloride liposome injection in subjects with advanced pancreatic cancer
主要研究目的:评价上海研诺医药科技有限公司的受试制剂盐酸伊立替康脂质体注射液与 Les Laboratoires Servier Industrie 的参比制剂盐酸伊立替康脂质体注射液(商品名:Onivyde)的生物等效性。次要研究目的:观察受试制剂盐酸伊立替康脂质体注射液(T)和参比制剂盐酸伊立替康脂质体注射液(R)在受试者中的安全性。
[Translation] The primary study objective is to evaluate the bioequivalence of the test preparation of irinotecan hydrochloride liposome injection from Shanghai Yannuo Pharmaceutical Technology Co., Ltd. and the reference preparation of irinotecan hydrochloride liposome injection (trade name: Onivyde) from Les Laboratoires Servier Industrie. The secondary study objective is to observe the safety of the test preparation of irinotecan hydrochloride liposome injection (T) and the reference preparation of irinotecan hydrochloride liposome injection (R) in subjects.