[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, two-sequence, double-crossover fasting/fed bioequivalence study of furosemide tablets in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂呋塞米片(持证商:江苏润恒制药有限公司)与参比制剂呋塞米片(持证商:Validus Pharmaceuticals LLC.,商品名:LASIX®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。 次要目的:观察受试制剂呋塞米片和参比制剂呋塞米片在健康受试者中的安全性。
[Translation] Primary objective: To compare the pharmacokinetic behavior of the test preparation furosemide tablets (licensed by: Jiangsu Runheng Pharmaceutical Co., Ltd.) and the reference preparation furosemide tablets (licensed by: Validus Pharmaceuticals LLC., trade name: LASIX®) in healthy subjects after oral administration in the fasting/postprandial state, using pharmacokinetic parameters as the primary endpoint evaluation indicators, and to evaluate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation furosemide tablets and the reference preparation furosemide tablets in healthy subjects.