[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test formulation, levetiracetam extended-release tablets (strength: 0.5 g), and the reference formulation, KEPPRA XR® (strength: 500 mg), in healthy adult subjects in the fasting and fed state.
主要研究目的:研究空腹和餐后状态下单次给药受试制剂左乙拉西坦缓释片(规格:0.5 g,东北制药集团沈阳第一制药有限公司生产)与参比制剂左乙拉西坦缓释片(KEPPRA XR®,规格:500 mg,UCB, Inc.生产)在健康受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂左乙拉西坦缓释片(规格:0.5 g)和参比制剂左乙拉西坦缓释片(KEPPRA XR®,规格:500 mg)在健康受试者中的安全性。
[Translation] Main research purpose: To study the single administration of the test preparation levetiracetam sustained-release tablets (specification: 0.5 g, produced by Northeast Pharmaceutical Group Shenyang First Pharmaceutical Co., Ltd.) and the reference preparation levetiracetam under fasting and postprandial conditions Pharmacokinetics of racetam extended-release tablets (KEPPRA
Secondary study objectives: To evaluate the efficacy of test formulation levetiracetam extended-release tablets (strength: 0.5 g) and reference formulation levetiracetam extended-release tablets (KEPPRA XR®, strength: 500 mg) in healthy subjects security in.