[Translation] A single-center, randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of G201-Na capsules in healthy premenopausal adult female subjects
主要目的:
1)评估在绝经前健康成年女性受试者中G201-Na胶囊单次给药的安全性和耐受性。
2)评估在绝经前健康成年女性受试者中G201-Na胶囊多次给药的安全性和耐受性。
次要目的:
1)评估绝经前健康成年女性受试者单次和多次口服不同剂量G201-Na胶囊后的药代动力学(PK)特征;
2)评估绝经前健康成年女性受试者单次和多次口服不同剂量G201-Na胶囊对体内促黄体生成素(LH)、卵泡刺激素(FSH)、雌二醇(E2)、孕酮(P)水平的影响,以及剂量、血药浓度和激素水平之间的关系。
3)评估绝经前健康成年女性受试者口服G201-Na胶囊后血药浓度与QT间期变化的关系。
[Translation] Main objectives:
1) To evaluate the safety and tolerability of single-dose G201-Na capsules in healthy premenopausal adult female subjects.
2) To evaluate the safety and tolerability of multiple-dose G201-Na capsules in healthy premenopausal adult female subjects.
Secondary objectives:
1) To evaluate the pharmacokinetic (PK) characteristics of single and multiple oral administration of different doses of G201-Na capsules in healthy premenopausal adult female subjects;
2) To evaluate the effects of single and multiple oral administration of different doses of G201-Na capsules on the levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2), and progesterone (P) in healthy premenopausal adult female subjects, as well as the relationship between dose, blood drug concentration, and hormone levels.
3) To evaluate the relationship between blood drug concentration and QT interval changes after oral administration of G201-Na capsules in healthy premenopausal adult female subjects.