[Translation] A single-center, randomized trial of Linezolid Tablets produced by Haikou Pharmaceutical Factory Co., Ltd. and Linezolid Tablets (trade name: Swan®/Zyvox®) licensed by Pfizer Pharmaceuticals.LLC in Chinese healthy subjects , open-label, two-drug, fasting and fed, single-dose, two-period, double-crossover design bioequivalence study
以海口市制药厂有限公司生产的利奈唑胺片(规格:600 mg)为受试制剂,持证商为Pfizer Pharmaceuticals.LLC的利奈唑胺片(商品名:斯沃®/Zyvox ®,规格:600 mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性,同时评价两制剂在健康受试者中的安全性
[Translation] Linezolid Tablets (Specification: 600 mg) produced by Haikou Pharmaceutical Factory Co., Ltd. was used as the test preparation, and the licensed manufacturer was Linezolid Tablets of Pfizer Pharmaceuticals.LLC (trade name: Swan®/Zyvox ®, Specification: 600 mg) as the reference preparation, investigate the pharmacokinetic parameters and relative bioavailability of the two preparations in a single administration under fasting and postprandial states, evaluate whether the two preparations have bioequivalence, and evaluate the health effects of the two preparations at the same time. Safety in subjects