[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of dapagliflozin tablets in healthy study participants under the fed state.
主要目的:健康研究参与者餐后状态下,口服单剂量达格列净片(Dapagliflozin Tablets,受试制剂T,山东诚创蓝海医药科技有限公司持有,远大生命科学(山东)有限公司生产,规格:10mg/片)与达格列净片(Dapagliflozin Tablets , 参比制剂R,AstraZeneca AB持有,AstraZeneca Pharmaceuticals LP生产,商品名:安达唐®/FORXIGA®,规格:10mg/片)进行生物等效研究,研究受试制剂与参比制剂在人体内的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察受试制剂达格列净片和参比制剂达格列净片(安达唐®/FORXIGA®)在健康研究参与者中的安全性。
[Translation] Primary Objective: To conduct a bioequivalence study comparing a single oral dose of dapagliflozin tablets (test formulation T, owned by Shandong Chengchuang Blue Ocean Pharmaceutical Technology Co., Ltd. and manufactured by Yuanda Life Sciences (Shandong) Co., Ltd., strength: 10 mg/tablet) with dapagliflozin tablets (reference formulation R, owned by AstraZeneca AB and manufactured by AstraZeneca Pharmaceuticals LP, trade name: Andatang®/FORXIGA®, strength: 10 mg/tablet) in healthy study participants after a meal. The study aimed to investigate the rate and extent of absorption of the test formulation and the reference formulation in humans and to evaluate their bioequivalence.
Secondary Objective: To observe the safety of the test formulation and the reference formulation (dapagliflozin tablets) in healthy study participants.