AUTHOR=Li Yinjuan , Qi Lu , Wang Yu , Li Yan , Lei Chunpu , Zhang Yingjuan , Cheng Xiaoqiang , Liu Ju , Bai HaiHong , Zhao Xia , Lv Shuzhen , Xiong Bingjun , Liu Juan , Shi Yehui , Zhou Huan , Li Hongtao , Liu Lihong , Jiang Hongchuan , Ouyang Weiwei , Li Xiaowen , Li Yanping , Wang Xinghe 

TITLE=A multicenter randomized trials to compare the bioequivalence and safety of a generic doxorubicin hydrochloride liposome injection with Caelyx ® in advanced breast cancer

JOURNAL=Frontiers in Oncology

VOLUME=Volume 12 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.1070001

DOI=10.3389/fonc.2022.1070001

ISSN=2234-943X

ABSTRACT=Purpose To compare the pharmacokinetic (PK) bioequivalence (BE) and safety of a generic pegylated liposomal doxorubicin (PLD) formulation with the reference product Caelyx®.
Methods A multicenter, single-dose, open-label, randomized，two-way crossover study was conducted in patients with breast cancer. For each period, the patients were administered with the test or the reference PLD intravenously at a dose of 50 mg/m2. Cmax, AUC0−t and AUC0−∞ for free, and encapsulated doxorubicin (doxorubicin) and partial AUC (AUC0−48h, AUC48h−t) for encapsulated doxorubicin were evaluated in 17 blood samples taken predose, and increasing time intervals over the following 14 days in each period. A washout period of 28-35 days was observed before crossing over.