[Translation] A randomized, open-label, single-dose, fasting and fed, two-formulation, two-cycle, double-crossover bioequivalence study of dienogest tablets in healthy adult Chinese subjects
本研究观察考察单次口服受试制剂地诺孕素片(规格:1mg,湖南醇健制药科技有限公司生产)与参比制剂地诺孕素片(规格:1mg,持田製薬株式会社生生产)在中国成年健康受试者体内的药代动力学特征,分别评价空腹与餐后状态下口服两种制剂的生物等效性
[Translation] This study observed and investigated the single oral administration of the test preparation dienogest tablets (specification: 1 mg, produced by Hunan Chunjian Pharmaceutical Technology Co., Ltd.) and the reference preparation dienogest tablets (specification: 1 mg, produced by Mochida Seiki Co., Ltd. ) in Chinese adult healthy subjects, and evaluate the bioequivalence of the two oral preparations in fasting and postprandial states.