[Translation] To evaluate the single-center, open-label, randomized, single-center, open-label, randomized, single-center, open-label, randomized, single-center, open-label, randomized, single-center, open-label, randomized, single-center, open-label, single-center, fasting and postprandial state of healthy adult subjects in healthy adult subjects. Dose, two-cycle, two-sequence, crossover bioequivalence study.
主要试验目的:研究空腹和餐后状态下单次口服受试制剂拉莫三嗪缓释片(规格:50 mg,上海奥科达生物医药科技有限公司委托浙江康恩贝制药股份有限公司生产)与参比制剂拉莫三嗪缓释片(Lamictal XR®,规格:50 mg;GlaxoSmithKline LLC生产)在健康受试者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。
次要试验目的:研究受试制剂拉莫三嗪缓释片(规格:50 mg)和参比制剂拉莫三嗪缓释片(Lamictal XR®,规格:50 mg)在健康受试者中的安全性。
[Translation] Main test purpose: To study the single oral administration of the test preparation lamotrigine sustained-release tablets in fasting and postprandial states (specification: 50 mg, commissioned by Shanghai Aokeda Biomedical Technology Co., Ltd. to produce Zhejiang Kangenbei Pharmaceutical Co., Ltd.) Pharmacokinetic profile of the reference formulation Lamotrigine Extended-Release Tablets (Lamictal XR®, strength: 50 mg; manufactured by GlaxoSmithKline LLC) in healthy subjects to evaluate the bioavailability of the two formulations orally in the fasting and postprandial states Equivalence.
Secondary trial objective: To study the effects of the test formulation lamotrigine extended-release tablets (strength: 50 mg) and the reference formulation lamotrigine extended-release tablets (Lamictal XR®, strength: 50 mg) in healthy subjects. safety.