[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence pilot study of dapagliflozin tablets in healthy study participants under fasting/fed conditions
主要目的:健康研究参与者空腹/餐后状态下,口服单剂量达格列净片(Dapagliflozin Tablets,受试制剂T,双鹤天安药业(贵州)股份有限公司生产,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)后,本次预试验主要考察空腹和餐后条件下受试制剂与参比制剂在健康研究参与者体内的药代动力学参数和个体内变异系数,验证血中药物浓度分析方法、采血时间、清洗期时间间隔等设置的合理性。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: After a single oral dose of dapagliflozin tablets (Dapagliflozin Tablets, test preparation T, produced by Shuanghe Tianan Pharmaceutical (Guizhou) Co., Ltd., specification: 10 mg/tablet) and dapagliflozin tablets (Dapagliflozin Tablets, reference preparation R, owned by AstraZeneca AB and produced by AstraZeneca Pharmaceuticals LP, trade name: Andatang®/FORXIGA®, specification: 10 mg/tablet) was administered to healthy study participants under fasting/postprandial conditions, this pilot study mainly investigated the pharmacokinetic parameters and intra-individual coefficient of variation of the test preparation and the reference preparation in healthy study participants under fasting and postprandial conditions, and verified the rationality of the blood drug concentration analysis method, blood collection time, washout period time interval and other settings. Secondary objective: To observe the safety of the test preparation dapagliflozin tablets and the reference preparation dapagliflozin tablets (Andatang®/FORXIGA®) in healthy study participants.