[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-period, double-crossover human bioequivalence trial of alprazolam tablets administered orally to participants in the Chinese Health Study under postprandial conditions.
研究健康研究参与者餐后单次口服受试制剂阿普唑仑片(广东南国药业有限公司,规格:0.4mg)与参比制剂阿普唑仑片(商品名:Solanax®;ヴィアトリス製薬株式会社,规格:0.4mg)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 alprazolam tablets (Guangdong Nanguo Pharmaceutical Co., Ltd., specification: 0.4 mg) and the reference formulation alprazolam tablets (trade name: Solanax®; Viatris Pharmaceutical Co., Ltd., specification: 0.4 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.