[Translation] A single-center, randomized, open, crossover bioequivalence clinical trial of recombinant human follicle-stimulating hormone injection JZB33 and GONAL-F®
以默克雪兰诺公司生产的重组人促卵泡激素注射液(果纳芬®)为参比制剂,以成都景泽生物制药有限公司提供的重组人促卵泡激素注射液(代号:JZB33)为受试制剂,通过单中心、随机、开放、双周期、交叉、单次皮下注射给药设计的生物等效性试验,评估两种制剂在中国健康成年女性受试者中应用的安全性、药代动力学行为及免疫原性,为产品上市提供参考依据。
[Translation] Using recombinant human follicle-stimulating hormone injection (GONA-f®) produced by Merck Serono as the reference preparation and recombinant human follicle-stimulating hormone injection (code: JZB33) provided by Chengdu Jingze Biopharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, two-period, crossover, single subcutaneous injection bioequivalence study was conducted to evaluate the safety, pharmacokinetic behavior and immunogenicity of the two preparations in healthy adult female subjects in China, so as to provide a reference for the product marketing.