[Translation] A single-center, randomized, open-label, two-dose, fasting, single-dose, four-period, completely repeated crossover design study of the relative bioavailability of HCD dry suspension developed by Zhejiang Shengbokang Pharmaceutical Co., Ltd. and the reference preparation in healthy Chinese menopausal female subjects
主要目的:考察空腹条件下HCD干混悬剂的药代动力学参数,验证血中药物浓度分析方法以及采血时间、采样量、时间间隔等设置的合理性,初步评价受试制剂较参比制剂的相对生物利用度,计算个体内变异系数,为正式试验的剂量选择、处方调整等提供指导。次要目的:观察健康绝经女性受试者单次空腹口服HCD干混悬剂和黄体酮软胶囊后的安全性。
[Translation] The main purpose is to investigate the pharmacokinetic parameters of HCD dry suspension under fasting conditions, verify the analysis method of drug concentration in blood and the rationality of blood sampling time, sampling volume, time interval, etc., preliminarily evaluate the relative bioavailability of the test preparation compared with the reference preparation, calculate the intra-individual coefficient of variation, and provide guidance for the dose selection and prescription adjustment of the formal trial. The secondary purpose is to observe the safety of healthy postmenopausal female subjects after a single fasting oral administration of HCD dry suspension and progesterone soft capsules.