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

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. C_max, AUC_0-t and AUC_0-∞ for free, and encapsulated doxorubicin (doxorubicin) and partial AUC (AUC_0-48h, AUC_48h-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 o

SUBMITTER: Li Y 

PROVIDER: S-EPMC9810385 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature