[Translation] A single-center, randomized, open-label, two-period, self-crossover, single-dose bioequivalence study of estradiol valerate tablets in healthy Chinese postmenopausal female participants under fasting and fed conditions
主要目的:考察空腹及餐后状态下单次口服受试制剂戊酸雌二醇片(规格:1 mg/片,武汉九珑人福药业有限责任公司生产)与参比制剂戊酸雌二醇片(补佳乐®,规格:1 mg/片;Jenapharm GmbH & Co. KG持证)在中国健康绝经后女性参与者体内的药代动力学特征,评价空腹及餐后状态口服两种制剂的生物等效性。次要目的:考察受试制剂戊酸雌二醇片(规格:1 mg/片)和参比制剂戊酸雌二醇片(补佳乐®,规格:1 mg/片)在中国健康绝经后女性参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of the test preparation estradiol valerate tablets (specification: 1 mg/tablet, produced by Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.) and the reference preparation estradiol valerate tablets (Progynova®, specification: 1 mg/tablet; certified by Jenapharm GmbH & Co. KG) in healthy Chinese postmenopausal 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 objective: To investigate the safety of the test preparation estradiol valerate tablets (specification: 1 mg/tablet) and the reference preparation estradiol valerate tablets (Progynova®, specification: 1 mg/tablet) in healthy Chinese postmenopausal female participants.