[Translation] A randomized, open-label, single-dose, double-crossover, fasting and fed bioequivalence study of melphalan tablets in patients with multiple myeloma and advanced ovarian cancer
主要目的:本次试验主要是以兆科(广州)肿瘤药物有限公司提供的美法仑片为受试制剂,按生物等效性研究的有关规定,以Excella GmbH & Co KG生产的原研药ALKERAN®(美法仑)为参比制剂,在中国肿瘤患者中的药代动力学特征,评价两种制剂的生物等效性。 次要研究目的:评价在中国肿瘤患者中应用口服美法仑片受试制剂和参比制剂的安全性。
[Translation] Main purpose: This test mainly uses Melphalan Tablets provided by Zhaoke (Guangzhou) Oncology Drug Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence research, the original drug ALKERAN produced by Excella GmbH & Co KG ® (Melphalan) as the reference preparation, the pharmacokinetic characteristics in Chinese cancer patients, and evaluate the bioequivalence of the two preparations. Secondary research purpose: To evaluate the safety of oral melphalan tablets test preparation and reference preparation in Chinese cancer patients.