[Translation] A single-center, randomized, open-label, two-period, crossover design study to evaluate the bioequivalence of a single oral dose of 0.6 g arginine ibuprofen granules in Chinese healthy adult subjects after fasting or after meals
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] Primary objective: To compare the bioequivalence of the two preparations in healthy adult Chinese subjects in the fasting and postprandial states, using the arginine ibuprofen granules (specification: 0.6 g (in terms of ibuprofen)) produced by Wenzhou Haihe Pharmaceutical Co., Ltd. as the test preparation and the arginine ibuprofen granules (specification: 0.6 g (in terms of ibuprofen), trade name: Spathik®) produced by Hainan Zanbang Pharmaceutical Co., Ltd. as the reference preparation. Secondary objective: To observe the safety of the test preparation arginine ibuprofen granules and the reference preparation Spathik® in healthy subjects.