[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-period, two-cycle, two-crossover human bioequivalence trial of a single oral dose of estazolam tablets after a meal in participants of the Chinese Health Study.
研究健康研究参与者餐后单次口服受试制剂艾司唑仑片(山西双雁药业有限公司,规格:1mg)与参比制剂艾司唑仑片(商品名:EURODIN®;Teva Takeda Yakuhin Ltd./武田テバ薬品株式会社,规格:1mg)在吸收程度和速度方面是否存在差异,评价受试制剂和参比制剂在餐后状态下给药时的生物等效性,观察受试制剂和参比制剂在健康研究参与者中的安全性。
[Translation] This study investigates whether there are differences in the absorption rate and extent between a single oral dose of the test formulation estazolam tablets (Shanxi Shuangyan Pharmaceutical Co., Ltd., specification: 1 mg) and the reference formulation estazolam tablets (trade name: EURODIN®; Teva Takeda Yakuhin Ltd./武田テバ薬品株式会社, specification: 1 mg) after a meal in healthy study participants. It also evaluates the bioequivalence of the test and reference formulations when administered after a meal and observes their safety in healthy study participants.