达格列净片在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉餐后状态下的生物等效性试验
[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of dapagliflozin tablets in healthy subjects under the fed state
主要目的:中国健康受试者餐后状态下,口服单剂量达格列净片(Dapagliflozin Tablets,受试制剂T,北京赛而生物药业有限公司生产,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®)在健康受试者中的安全性。
[Translation] Primary objective: To conduct a bioequivalence study on a single oral dose of dapagliflozin tablets (test preparation T, produced by Beijing Saier Biopharmaceutical 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) in healthy Chinese subjects in the postprandial state, to study the absorption rate and extent of the test preparation and the reference preparation in the human body, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation dapagliflozin tablets and the reference preparation dapagliflozin tablets (Andatang®/FORXIGA®) in healthy subjects.
达格列净片在健康受试者中随机、 开放、 单剂量、 两制剂、 两序列、 两周期交
叉空腹状态下的生物等效性试验
[Translation] A randomized, open, single-dose, two-formulation, two-sequence, two-cycle crossover bioequivalence study of dapagliflozin tablets in healthy subjects under fasting conditions
主要目的:中国健康受试者空腹状态下,口服单剂量达格列净片(Dapagliflozin Tablets,受试制剂T,北京赛而生物药业有限公司生产,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®)在健康受试者中的安全性。
[Translation] Primary objective: To conduct a bioequivalence study on a single oral dose of dapagliflozin tablets (test preparation T, produced by Beijing Saier Biopharmaceutical Co., Ltd., specification: 10 mg/tablet) and dapagliflozin tablets (dapagliflozin tablets, reference preparation R, owned by AstraZeneca AB, produced by AstraZeneca Pharmaceuticals LP, trade name: Andatang®/FORXIGA®, specification: 10 mg/tablet) in healthy Chinese subjects under fasting state, to study the absorption rate and extent of the test preparation and the reference preparation in the human body, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation dapagliflozin tablets and the reference preparation dapagliflozin tablets (Andatang®/FORXIGA®) in healthy subjects.
100 Clinical Results associated with Beijing Saier Biological Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Beijing Saier Biological Pharmaceutical Co., Ltd.
100 Deals associated with Beijing Saier Biological Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Beijing Saier Biological Pharmaceutical Co., Ltd.