[Translation] A single-center, randomized, open-label, single-dose, four-period, two-sequence, fully repeated crossover bioequivalence study to evaluate the test preparation Voglibose Tablets (strength: 0.2 mg) and the reference preparation Basen® (strength: 0.2 mg) in healthy adult participants under fasting state
主要目的:研究空腹状态下单次口服受试制剂伏格列波糖片(规格:0.2 mg,浙江京新药业股份有限公司生产)与参比制剂伏格列波糖片(倍欣®,规格:0.2 mg,天津武田药品有限公司生产)在健康参与者体内的药效动力学,评价空腹状态口服两种制剂的生物等效性。
次要目的:评估受试制剂伏格列波糖片(规格:0.2 mg)和参比制剂伏格列波糖片(倍欣®,规格:0.2 mg)在健康参与者中的安全性。
[Translation] Primary objective: To study the pharmacodynamics of a single oral dose of the test preparation voglibose tablets (specification: 0.2 mg, produced by Zhejiang Jingxin Pharmaceutical Co., Ltd.) and the reference preparation voglibose tablets (Bexin®, specification: 0.2 mg, produced by Tianjin Takeda Pharmaceutical Co., Ltd.) in healthy participants under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions.
Secondary objective: To evaluate the safety of the test preparation voglibose tablets (specification: 0.2 mg) and the reference preparation voglibose tablets (Bexin®, specification: 0.2 mg) in healthy participants.