[Translation] A single-center, randomized, open-label, single-dose, two-dose, four-period, two-sequence, fully repeated crossover bioequivalence study of oxcarbazepine tablets versus the reference product (Trileptal®) in healthy subjects under fasting and fed dosing conditions.
本试验旨在研究单次空腹和餐后口服杭州和康药业有限公司研制、生产的奥卡西平片(0.3 g)的药代动力学特征;以Novartis Farma S.p.A生产的奥卡西平片(曲莱®,0.3 g)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of oxcarbazepine tablets (0.3 g) developed and produced by Hangzhou Hekang Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using oxcarbazepine tablets (Trilep®, 0.3 g) produced by Novartis Farma S.p.A. as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.