[Translation] A single-center, single-dose, fasting, 2-drug, 3-period, 3-sequence, open-label, randomized, partially replicated (only the reference product was replicated) average bioequivalence study in healthy subjects.
主要目的:健康绝经后女性受试者空腹单剂量给予黄体酮阴道缓释凝胶(受试制剂,浙江爱生药业有限公司生产)与原研药黄体酮阴道缓释凝胶(参比制剂,雪诺同,MERCK SERONO LIMITED持证)后,测定血浆中黄体酮的浓度,研究受试制剂与参比制剂的吸收速度和程度,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To determine the concentration of progesterone in plasma after a single dose of progesterone vaginal sustained-release gel (test preparation, produced by Zhejiang Aisheng Pharmaceutical Co., Ltd.) and original progesterone vaginal sustained-release gel (reference preparation, Xuenuotong, licensed by MERCK SERONO LIMITED) was given to healthy postmenopausal female subjects on an empty stomach, to study the absorption rate and extent of the test preparation and the reference preparation, and to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.