[Translation] A randomized, open-label, single-dose, parallel-design comparative pharmacokinetic study of leuprorelin acetate microspheres for injection in postmenopausal women
主要目的:
受试制剂注射用醋酸亮丙瑞林微球(规格:11.25 mg,自研)与参比制剂注射用醋酸亮丙瑞林微球(商品名:ENANTONE/抑那通,规格:11.25 mg,Takeda Pharmaceutical Company Limited持有)在绝经后女性参与者体内的药代动力学对比研究,比较两种制剂在空腹条件下单次给药的药代动力学相似性。
次要目的:
评估单剂注射受试制剂(注射用醋酸亮丙瑞林微球,T)和参比制剂(ENANTONE/抑那通,R)在绝经后女性参与者中的安全性。
[Translation] Primary Objective:
To conduct a comparative pharmacokinetics study of the test formulation, leuprorelin acetate microspheres for injection (11.25 mg, in-house developed), and the reference formulation, leuprorelin acetate microspheres for injection (trade name: ENANTONE, 11.25 mg, owned by Takeda Pharmaceutical Company Limited), in postmenopausal women. The pharmacokinetic similarity of the two formulations following a single dose under fasting conditions was compared.
Secondary Objective:
To evaluate the safety of a single injection of the test formulation (leuprorelin acetate microspheres for injection, T) and the reference formulation (ENANTONE, R) in postmenopausal women.