[Translation] A single-center, randomized, open-label, two-period, crossover design to evaluate the human bioequivalence of 0.6 g of arginine ibuprofen granules after fasting and after meals in healthy Chinese adult subjects
主要目的:以温州海鹤药业有限公司生产的精氨酸布洛芬颗粒(规格:0.6g(以布洛芬计))为受试制剂,以海南赞邦制药有限公司生产的精氨酸布洛芬颗粒(规格:0.6g(以布洛芬计),商品名:司百得®)为参比制剂,比较两种制剂在中国健康成年受试者空腹及餐后状态下的生物等效性。 次要目的:观察受试制剂精氨酸布洛芬颗粒和参比制剂司百得®在健康受试者中的安全性。
[Translation] Main purpose: Take arginine ibuprofen granules (specification: 0.6g (calculated as ibuprofen)) produced by Wenzhou Haihe Pharmaceutical Co., Ltd. Ibuprofen granules (specification: 0.6g (calculated as ibuprofen), trade name: Spyder®) were used as reference preparations to compare the biological properties of the two preparations in Chinese healthy adult subjects in fasting and postprandial states. effectiveness. Secondary objective: To observe the safety of the test preparation arginine ibuprofen granules and the reference preparation Spetech® in healthy subjects.