盐酸多柔比星脂质体注射液在乳腺癌患者的多中心、随机、开放、单剂量、两周期、双交叉的人体生物等效性试验。
[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.
Pegylated Liposomal Doxorubicin-contained Versus Daunorubicin-contained VDCLD Regimen in Previously Untreated Adult Patients With Acute Lymphoblastic Leukemia: Complete Remission Rates and Changes of Leukemia Stem Cells
To determine, compared with Daunorubicin(DNR), whether Pegylated liposomal doxorubicin (PLD) inducing higher complete remission (CR) rate, in untreated primary ALL adult patients with VDCLD regimen induction therapy. Second, to determine, compared with the DNR, whether chemotherapy containing PLD with a higher response rates and greater safety in adult ALL
研究受试者分别在空腹和餐后状态下单次口服受试制剂或参比制剂后的药代动力学参数,评价两制剂的生物等效性
[Translation] The pharmacokinetic parameters of the test preparation or reference preparation after a single oral administration in the fasting and fed state were studied to evaluate the bioequivalence of the two preparations.
研究受试者分别在空腹和餐后状态下单次口服常州制药厂有限公司生产的瑞舒伐他汀钙片(T,5 mg/片)与IPR PHARMACEUTICALS INCORPORATED生产、阿斯利康制药有限公司分装的瑞舒伐他汀钙片(R,可定,5 mg/片)后的相关药代动力学参数,评价两制剂的生物等效性。
[Translation] The relevant pharmacokinetic parameters of rosuvastatin calcium tablets (T, 5 mg/tablet) produced by Changzhou Pharmaceutical Factory Co., Ltd. and rosuvastatin calcium tablets (R, Crestin, 5 mg/tablet) produced by IPR PHARMACEUTICALS INCORPORATED and packaged by AstraZeneca Pharmaceuticals Co., Ltd. were compared after a single oral administration in the fasting and fed states, and the bioequivalence of the two preparations was evaluated.
100 Clinical Results associated with Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.
0 Patents (Medical) associated with Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.
100 Deals associated with Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.
100 Translational Medicine associated with Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.