[Translation] Randomized, open-label, three-cycle, three-sequence, partially replicated crossover bioequivalence trial of single-dose oxcarbazepine oral suspension in healthy subjects under fasting and high-fat postprandial administration conditions
以药代动力学参数为终点指标,比较空腹和高脂餐后给药条件下,四川科瑞德制药股份有限公司生产的奥卡西平口服混悬液与Novartis Pharma Schweiz AG原研进口的奥卡西平口服混悬液(商品名:曲莱®/Trileptal®)在健康成年人群中吸收程度和速度的差异,对两制剂的生物等效性进行评价,并评价空腹和高脂餐后给药条件下,四川科瑞德制药股份有限公司生产的奥卡西平口服混悬液在健康成年人群中的安全性。
[Translation] Using pharmacokinetic parameters as endpoints, we compared oxcarbazepine oral suspension produced by Sichuan Creed Pharmaceutical Co., Ltd. and oxcarbazepine imported from Novartis Pharma Schweiz AG under fasting and high-fat postprandial administration conditions. To evaluate the differences in the degree and rate of absorption of oral suspension (trade name: Trileptal®/Trileptal®) in healthy adults, to evaluate the bioequivalence of the two preparations, and to evaluate the administration conditions of fasting and high-fat meals , the safety of oxcarbazepine oral suspension produced by Sichuan Creed Pharmaceutical Co., Ltd. in healthy adults.