[Translation] A multicenter, randomized, open-label, single-dose, two-period, double-crossover human bioequivalence trial of doxorubicin hydrochloride liposome injection in patients with breast cancer.
主要目的 以Janssen-Cilag公司生产的盐酸多柔比星脂质体注射液(商品名:Caelyx®,规格:10mL:20mg)为参比制剂,按照生物等效性试验的有关规定,与常州金远药业制造有限公司生产的受试制剂盐酸多柔比星脂质体注射液(商品名:立幸;规格:10mL:20mg)进行体内药动学对比研究,考察多柔比星在乳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 研究受试制剂盐酸多柔比星脂质体注射液(规格:10mL:20mg)和参比制剂盐酸多柔比星脂质体注射液Caelyx®(规格:10mL:20mg)在乳腺癌患者中的安全性。
[Translation] Main objective: Using doxorubicin hydrochloride liposome injection (trade name: Caelyx®, specification: 10mL:20mg) produced by Janssen-Cilag as the reference preparation, in accordance with the relevant provisions of the bioequivalence test, a comparative in vivo pharmacokinetics study was conducted with the test preparation doxorubicin hydrochloride liposome injection (trade name: Lixing; specification: 10mL:20mg) produced by Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd. to investigate the pharmacokinetic behavior of doxorubicin in breast cancer patients and evaluate the bioequivalence of the two preparations. Secondary objective: To study the safety of the test preparation doxorubicin hydrochloride liposome injection (specification: 10mL:20mg) and the reference preparation doxorubicin hydrochloride liposome injection Caelyx® (specification: 10mL:20mg) in breast cancer patients.