[Translation] A single-center, open-label, randomized, single-dose, four-period, two-sequence, fully repeated crossover bioequivalence study was conducted to evaluate the bioequivalence of the test formulation, dydrogesterone tablets (strength: 10 mg), and the reference formulation (Duphaston®) (strength: 10 mg) in healthy adult female participants under fasting and fed conditions.
主要试验目的:研究空腹和餐后状态下单次口服受试制剂地屈孕酮片(规格:10 mg,浙江美迪深生物医药有限公司持证)与参比制剂地屈孕酮片(达芙通®/Duphaston®,规格:10 mg;Abbott Biological B.V.生产)在健康女性参与者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。
次要试验目的:研究受试制剂地屈孕酮片(规格:10 mg)和参比制剂地屈孕酮片(达芙通®/Duphaston®,规格:10 mg)在健康女性参与者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Dydrogesterone Tablets (Specification: 10 mg, licensed by Zhejiang Medishen Biopharmaceutical Co., Ltd.) and the reference preparation Dydrogesterone Tablets (Duphaston®/Duphaston®, Specification: 10 mg; produced by Abbott Biological B.V.) in healthy female participants after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary purpose of the study is to study the safety of the test preparation Dydrogesterone Tablets (Specification: 10 mg) and the reference preparation Dydrogesterone Tablets (Duphaston®/Duphaston®, Specification: 10 mg) in healthy female participants.