[Translation] A study evaluating the combination of 900 IU follicle-stimulating hormone alfa (Gonafin) + 450 IU luteinizing hormone alfa (Lerui) combined with subcutaneous (SC) Pergoveris (SC) in healthy premenopausal Chinese female subjects with pituitary suppression. An open-label, randomized, three-period, crossover, single-center Phase I study of the bioequivalence of a liquid and lyophilized (FD) formulation containing 900 IU of follicle-stimulating hormone alfa + 450 IU of luteinizing hormone alfa.
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] main purpose:
To evaluate the bioequivalence (BE) of Pergoveris lyophilized formulation (test formulation 1) in combination with each of its components (Gonafin and Lerui, reference formulation) in pituitary-suppressed healthy Chinese female subjects , the medication method is 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 each of its components (Gonafin and Lerui, reference formulation) in pituitary-suppressed healthy Chinese female subjects by subcutaneous injection of 900 IU follicle-stimulating hormone alpha/450 IU luteinizing hormone alfa.
Secondary purpose:
To evaluate the safety and tolerability of Pergoveris lyophilized formulation and Pergoveris liquid formulation in healthy Chinese female subjects with pituitary suppression.
Assess other pharmacokinetic (PK) parameters following single-dose administration of test and reference products