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Clinical Trials associated with Follicle stimulating hormone biosimilar (Genescience Pharma) / CompletedNot Applicable 重组人促卵泡激素注射液与注射用重组人促卵泡激素在中国健康成年女性中的生物等效性研究
[Translation] Bioequivalence study of recombinant human follicle-stimulating hormone injection and recombinant human follicle-stimulating hormone for injection in healthy Chinese adult women
主要目的
健康成年女性单剂量皮下注射受试制剂(T=重组人促卵泡激素注射液,代号GenSci008)和参比制剂(R=注射用重组人促卵泡激素,商品名:金赛恒®),评价两种制剂的药代动力学(PK)特征,验证两种制剂是否具有生物等效性。
次要目的
评价重组人促卵泡激素注射液(代号 GenSci008)在健康成年女性人群中的安全性和免疫原性。
[Translation] Primary objective
The test preparation (T = recombinant human follicle-stimulating hormone injection, code name GenSci008) and the reference preparation (R = recombinant human follicle-stimulating hormone for injection, trade name: Jinsaiheng®) were injected subcutaneously into healthy adult females to evaluate the pharmacokinetic (PK) characteristics of the two preparations and verify whether the two preparations are bioequivalent.
Secondary objective
Evaluate the safety and immunogenicity of recombinant human follicle-stimulating hormone injection (code name GenSci008) in healthy adult females.
100 Clinical Results associated with Follicle stimulating hormone biosimilar (Genescience Pharma)
100 Translational Medicine associated with Follicle stimulating hormone biosimilar (Genescience Pharma)
100 Patents (Medical) associated with Follicle stimulating hormone biosimilar (Genescience Pharma)
100 Deals associated with Follicle stimulating hormone biosimilar (Genescience Pharma)