[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test product, estradiol valerate tablets (strength: 1 mg), and the reference product (Progynova®, strength: 1 mg) in healthy postmenopausal female subjects under fasting and fed conditions.
主要研究目的:评估空腹和餐后状态下单次口服受试制剂戊酸雌二醇片(规格:1mg,河南泰丰生物科技有限公司生产)与参比制剂戊酸雌二醇片(Progynova®,规格:1mg,Jenapharm GmbH & Co. KG持证)在健康绝经后女性受试者体内的药代动力学参数,并为正式研究提供数据参考。
次要研究目的:评估受试制剂戊酸雌二醇片(规格:1 mg)和参比制剂戊酸雌二醇片(Progynova®,规格:1 mg)在健康绝经后女性受试者中的安全性。
[Translation] The main purpose of the study is to evaluate the pharmacokinetic parameters of the test preparation estradiol valerate tablets (specification: 1 mg, produced by Henan Taifeng Biotechnology Co., Ltd.) and the reference preparation estradiol valerate tablets (Progynova®, specification: 1 mg, certified by Jenapharm GmbH & Co. KG) in healthy postmenopausal female subjects after a single oral administration under fasting and postprandial conditions, and to provide data reference for formal research.
Secondary purpose of the study is to evaluate the safety of the test preparation estradiol valerate tablets (specification: 1 mg) and the reference preparation estradiol valerate tablets (Progynova®, specification: 1 mg) in healthy postmenopausal female subjects.