[Translation] A randomized, open-label, single-dose, fasting and fed, two-formulation, two-period, double-crossover bioequivalence study of dienogest tablets in healthy adult Chinese subjects
主要目的:考察单次口服2mg(空腹/餐后)受试制剂地诺孕素片[规格:2mg,博瑞制药(苏州)有限公司提供,浙江仙琚制药股份有限公司生产]与参比制剂地诺孕素片(唯散宁®/Visanne®,规格:2mg,Bayer Weimar GmbH und Co. KG生产),在中国成年女性健康受试者体内的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要目的:评价受试制剂和参比制剂单次口服2 mg(空腹/餐后)在中国成年女性健康受试者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic parameters of a single oral dose of 2 mg (fasting/after meals) of the test preparation Dienogest Tablets [Specification: 2 mg, provided by Borri Pharmaceuticals (Suzhou) Co., Ltd., produced by Zhejiang Xianjun Pharmaceutical Co., Ltd.] and the reference preparation Dienogest Tablets (Visanne®/Visanne®, Specification: 2 mg, produced by Bayer Weimar GmbH und Co. KG) in healthy adult female subjects in China, to evaluate the bioequivalence of the two preparations, and to provide a reference for the application and clinical use of the drug.
Secondary objective: To evaluate the safety of a single oral dose of 2 mg (fasting/after meals) of the test preparation and the reference preparation in healthy adult female subjects in China.