[Translation] A randomized, open-label, two-dose, two-period, crossover, fasting and fed bioequivalence study of dapagliflozin tablets in healthy volunteers
主要目的:研究健康受试者在空腹/餐后状态下,单次口服由山东鲁抗医药集团赛特有限责任公司生产的达格列净片10mg(受试制剂)和阿斯利康(AstraZenecaAB)为持证商的原研达格列净片10mg(FORXIGA/安达唐,参比制剂)的相对生物利用度,评价受试制剂与参比制剂间的生物等效性。
次要目的:通过不良事件发生率、实验室检验结果、生命体征和体格检查等的变化情况观察受试制剂和参比制剂在中国健康受试者中的安全性和耐受性。
[Translation] Primary objective: To study the relative bioavailability of dapagliflozin tablets 10 mg (test preparation) produced by Shandong Lukang Pharmaceutical Group Saite Co., Ltd. and original dapagliflozin tablets 10 mg (FORXIGA/Andatang, reference preparation) of AstraZeneca AB as the licensee in healthy subjects in the fasting/postprandial state, and to evaluate the bioequivalence between the test preparation and the reference preparation.
Secondary objective: To observe the safety and tolerability of the test preparation and the reference preparation in healthy Chinese subjects through changes in adverse event incidence, laboratory test results, vital signs and physical examinations.