[Translation] Bioequivalence study of estradiol tablets/estradiol dydrogesterone tablets combined packaging [A randomized, open, two-sequence, four-period, completely repeated crossover design bioequivalence study of estradiol dydrogesterone tablets in a combined package of estradiol tablets/estradiol dydrogesterone tablets taken orally in healthy postmenopausal female subjects in the fasting and fed states.
主要试验目的:
研究空腹、餐后状态下分别单次口服受试制剂雌二醇片/雌二醇地屈孕酮片复合包装(生产厂家:北京金城泰尔制药有限公司)中雌二醇地屈孕酮片(规格:含雌二醇2mg和地屈孕酮10mg)与参比制剂雌二醇片/雌二醇地屈孕酮片复合包装(商品名:芬吗通®,生产厂家:Abbott Biologicals B.V.,持证商:Abbott B.V.)中雌二醇地屈孕酮片(规格:含雌二醇2mg和地屈孕酮10mg)在中国健康绝经后女性受试者体内的药代动力学行为,评价空腹、餐后状态口服雌二醇片/雌二醇地屈孕酮片复合包装中雌二醇地屈孕酮片两种制剂的生物等效性。
次要试验目的:
评价中国健康绝经后女性受试者空腹/餐后状态下分别单次口服雌二醇片/雌二醇地屈孕酮片复合包装中雌二醇地屈孕酮片的两种制剂后的安全性。
[Translation] Main purpose of the study:
To study the pharmacokinetic behavior of the test preparation estradiol tablets/estradiol dydrogesterone tablets (specification: containing 2 mg estradiol and 10 mg dydrogesterone) in the combined package of estradiol tablets/estradiol dydrogesterone tablets (manufacturer: Beijing Jincheng Taier Pharmaceutical Co., Ltd.) and the reference preparation estradiol tablets/estradiol dydrogesterone tablets (trade name: Fentaton®, manufacturer: Abbott Biologicals B.V., licensee: Abbott B.V.) in healthy postmenopausal female subjects in China after a single oral dose in the fasting and postprandial states, and to evaluate the bioequivalence of the two preparations of estradiol dydrogesterone tablets in the combined package of estradiol tablets/estradiol dydrogesterone tablets.
Secondary study objective: To evaluate the safety of two preparations of estradiol dydrogesterone tablets in the combined package of estradiol tablets/estradiol dydrogesterone tablets in Chinese healthy postmenopausal female subjects after a single oral administration in the fasting/postprandial state.