[Translation] An open-label, randomized, two-way crossover, single-dose, bioequivalence trial to compare high-purity gonadotropin injection (Hemeiqi® prefilled injection pen) with high-purity gonadotropin for injection (Hemeiqi®) after subcutaneous administration in healthy women.
主要目的:就促卵泡激素(FSH)随时间变化的总暴露量和最大暴露量,证明贺美奇注射笔和贺美奇粉剂的生物等效性
次要目的: 比较贺美奇注射笔和贺美奇粉剂的FSH、人绒毛膜促性腺激素(hCG)和黄体生成素(LH)的药代动力学(PK)参数
比较贺美奇注射笔与贺美奇粉剂的安全性
[Translation] Primary objective: To demonstrate the bioequivalence of the Hemeiqi Pen and Hemeiqi Powder in terms of total exposure and maximum exposure of follicle stimulating hormone (FSH) over time
Secondary objective: To compare the pharmacokinetic (PK) parameters of FSH, human chorionic gonadotropin (hCG) and luteinizing hormone (LH) between the Hemeiqi Pen and Hemeiqi Powder
To compare the safety of the Hemeiqi Pen and Hemeiqi Powder