[Translation] A single-center, open-label, randomized, single-dose, two-cycle, two-crossover bioequivalence study of progesterone injection in healthy postmenopausal women
主要研究目的:本研究以成都倍特得诺药业有限公司生产的黄体酮注射液(1.112ml:25mg)为受试制剂,原研IBSA Farmaceutici Italia Srl生产的黄体酮注射液(1.112ml:25mg,商品名:Lubion®)为参比制剂,评价受试制剂和参比制剂的生物等效性。
次要研究目的:观察受试制剂和参比制剂在健康绝经后女性中的安全性。
[Translation] Main research purpose: This study uses progesterone injection (1.112ml:25mg) produced by Chengdu Beitedenuo Pharmaceutical Co., Ltd. as the test preparation and progesterone injection (1.112ml:25mg, trade name: Lubion®) produced by the original IBSA Farmaceutici Italia Srl as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary research purpose: To observe the safety of the test preparation and the reference preparation in healthy postmenopausal women.