[Translation] An open-label, randomized, two-way crossover, single-dose, bioequivalence trial to compare high-purity urinary gonadotropin injection (Hemeiqi® prefilled injection pen) with injection after subcutaneous administration in healthy women High-purity urinary gonadotropin (Hemeiqi®)
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] Main objective: To demonstrate the bioequivalence of Hemeiqi injection pen and Hemeiqi powder in terms of total and maximum exposure to follicle-stimulating hormone (FSH) over time
Secondary objective: To compare the pharmacokinetic (PK) parameters of FSH, human chorionic gonadotropin (hCG) and luteinizing hormone (LH) of Hemeiqi injection pen and Hemeiqi powder
Comparison of the safety of Hemeiqi injection pen and Hemeiqi powder