[Translation] Single-center, randomized, open-label, two-preparation, single-dose, two-cycle, double-crossover fasting bioequivalence trial of ibuprofen arginine granules 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,比较在空腹状态下口服受试制剂精氨酸布洛芬颗粒(生产厂家:金鸿药业股份有限公司)与参比制剂精氨酸布洛芬颗粒(持证商:海南赞邦制药有限公司,商品名:司百得®)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:观察受试制剂精氨酸布洛芬颗粒和参比制剂精氨酸布洛芬颗粒在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the oral administration of the test preparation Arginine Ibuprofen Granules (manufacturer: Jinhong Pharmaceutical Co., Ltd.) and the reference preparation Arginine in the fasting state. Pharmacokinetic behavior of ibuprofen granules (license holder: Hainan Zambon Pharmaceutical Co., Ltd., trade name: Sibide®) in healthy subjects to evaluate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation Arginine Ibuprofen Granules and the reference preparation Arginine Ibuprofen Granules in healthy subjects.