中国健康女性受试者空腹和餐后状态下口服地屈孕酮片的随机、开放、两序列、四周期重复交叉设计生物等效性试验
[Translation] A randomized, open-label, two-sequence, four-period repeated crossover bioequivalence study of oral dydrogesterone tablets in Chinese healthy female subjects in the fasting and fed state
主要研究目的
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:10mg,浙江赛默制药有限公司生产)与参比制剂地屈孕酮片(商品名:达芙通®,规格:10mg,Abbott Biologicals B.V.生产)在中国健康女性受试者体内的药代动力学,评价两制剂生物等效性。
次要研究目的
评价中国健康女性受试者空腹和餐后单次口服受试制剂(T)地屈孕酮片和参比制剂(R)地屈孕酮片(达芙通®)后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation Dydrogesterone Tablets (Specification: 10 mg, produced by Zhejiang Thermo Pharmaceutical Co., Ltd.) and the reference preparation Dydrogesterone Tablets (trade name: Duphaston®, specification: 10 mg, produced by Abbott Biologicals B.V.) in healthy Chinese female subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations.
Secondary study objectives
To evaluate the safety of the test preparation (T) Dydrogesterone Tablets and the reference preparation (R) Dydrogesterone Tablets (Duphaston®) after a single oral administration in healthy Chinese female subjects after fasting and feeding.
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