[Translation] A single-dose, randomized, open-label, two-sequence, two-period, self-crossover bioequivalence study of dienogest tablets in Chinese healthy female subjects under fasting and fed conditions
主要研究目的:研究空腹/餐后状态下单次口服受试制剂地诺孕素片(规格:2mg,上海华源安徽锦辉制药有限公司生产)与参比制剂地诺孕素片(商品名:唯散宁/Visanne,规格:2mg,Jenapharm GmbH&CO.KG持证)在健康成年女性受试者体内的药代动力学,评价空腹/餐后状态口服两种制剂的生物等效性。
次要研究目的:观察受试制剂地诺孕素片和参比制剂地诺孕素片(唯散宁)在健康成年女性受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation Dienogest Tablets (Specification: 2mg, produced by Shanghai Huayuan Anhui Jinhui Pharmaceutical Co., Ltd.) and the reference preparation Dienogest Tablets (trade name: Visanne, specification: 2mg, certified by Jenapharm GmbH & CO.KG) in healthy adult female subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary purpose of the study: to observe the safety of the test preparation Dienogest Tablets and the reference preparation Dienogest Tablets (Visanne) in healthy adult female subjects.