[Translation] A randomized, open-label, two-cycle, two-crossover study comparing the safety and pharmacokinetics of recombinant human follicle-stimulating hormone injection LM001 and GONAL-F in healthy female subjects
主要研究目的
以康宁杰瑞(吉林)生物科技有限公司提供的重组人促卵泡激素注射液(代号:LM001)为受试制剂,按有关生物等效性试验的规定,以默克雪兰诺生产的重组人促卵泡激素注射液果纳芬为参比制剂,进行人体药代动力学比对研究。
次要研究目的
观察受试制剂LM001和参比制剂果纳芬®在健康受试者中的安全性。
[Translation] Main research purpose
The recombinant human follicle stimulating hormone injection (code: LM001) provided by Alphamab Oncology (Jilin) Biotechnology Co., Ltd. was used as the test preparation. According to the relevant provisions of the bioequivalence test, the recombinant human follicle stimulating hormone injection Gonal-f produced by Merck Serono was used as the reference preparation for a human pharmacokinetic comparison study.
Secondary research purpose
To observe the safety of the test preparation LM001 and the reference preparation Gonal-f® in healthy subjects.