[Translation] Bioequivalence of oxcarbazepine oral suspension (60 mg/ml) in a randomized, open-label, two-dose, single-dose, four-cycle, two-sequence, full repeat crossover, postprandial state in healthy Chinese subjects test
主要目的:以广东品晟医药科技有限公司提供的奥卡西平口服混悬液为受试制剂,按生物等效性试验的有关规定,与Novartis Pharma Schweiz AG为持证商的奥卡西平口服混悬液(商品名:曲莱)(参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。次要目的:观察受试制剂奥卡西平口服混悬液和参比制剂奥卡西平口服混悬液(商品名:曲莱)在健康受试者中的安全性。
[Translation] Main purpose: Take the oxcarbazepine oral suspension provided by Guangdong Pinsheng Pharmaceutical Technology Co., Ltd. as the test preparation, and according to the relevant regulations of the bioequivalence test, and Novartis Pharma Schweiz AG is the licensee of the oxcarbazepine oral mixture. The suspension (trade name: Qulai) (reference preparation) was compared with the absorption rate and absorption degree in healthy human body, and the human bioequivalence of the two preparations was investigated. Secondary objective: To observe the safety of test preparation oxcarbazepine oral suspension and reference preparation oxcarbazepine oral suspension (trade name: Trilei) in healthy subjects.