[Translation] This is an open-label, randomized, three-period crossover, single-center, phase I study evaluating the bioequivalence of the combination of 900 IU follicle-stimulating hormone alfa (GONA-F) + 450 IU luteinizing hormone alfa (LURIS) compared with subcutaneous (SC) injection of liquid and freeze-dried (FD) formulations of Pergoveris (a fixed combination of 900 IU follicle-stimulating hormone alfa + 450 IU luteinizing hormone alfa) in healthy Chinese women with pituitary suppression and premenopausal status.
主要目的:
评估Pergoveris冻干制剂(受试制剂1)与其中各个组分(果纳芬和乐芮,参比制剂)联合给药在垂体抑制的中国健康女性受试者中的生物等效性(BE),用药方法为皮下(SC)注射900 IU促卵泡激素α/450 IU促黄体激素α。
评估Pergoveris液体制剂(受试制剂2)与其中各个组分(果纳芬和乐芮,参比制剂)联合给药在垂体抑制的中国健康女性受试者中的BE,用药方法为皮下注射900 IU促卵泡激素α/450 IU促黄体激素α。
次要目的:
评价Pergoveris 冻干制剂和Pergoveris 液体制剂在垂体抑制的中国健康女性受试者中的安全性和耐受性。
评估单剂量使用受试制剂和参比制剂后的其他药代动力学(PK)参数
[Translation] Primary objectives:
To evaluate the bioequivalence (BE) of Pergoveris lyophilized formulation (test formulation 1) in combination with its individual components (GONAL-F and LERI, reference formulation) in healthy Chinese female subjects with pituitary suppression, with a subcutaneous (SC) injection of 900 IU follicle-stimulating hormone alpha/450 IU luteinizing hormone alpha.
To evaluate the BE of Pergoveris liquid formulation (test formulation 2) in combination with its individual components (GONAL-F and LERI, reference formulation) in healthy Chinese female subjects with pituitary suppression, with a subcutaneous injection of 900 IU follicle-stimulating hormone alpha/450 IU luteinizing hormone alpha.
Secondary objectives:
To evaluate the safety and tolerability of Pergoveris lyophilized formulation and Pergoveris liquid formulation in healthy Chinese female subjects with pituitary suppression.
To evaluate other pharmacokinetic (PK) parameters after single-dose administration of test formulation and reference formulation