[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of linezolid tablets (600 mg) in Chinese healthy subjects under fasting and fed conditions
主要研究目的:以Pfizer Pharmaceuticals.LCC持证的利奈唑胺片(600 mg)为参比制剂,以浙江杭康药业有限公司研发的利奈唑胺片(600 mg)为受试制剂,通过单中心、单次给药、随机、开放、两周期、双交叉设计的临床研究来评价两种制剂在空腹和餐后状态下的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the linezolid tablets (600 mg) certified by Pfizer Pharmaceuticals.LCC as the reference preparation and the linezolid tablets (600 mg) developed by Zhejiang Hangkang Pharmaceutical Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations in the fasting and fed state through a single-center, single-dose, randomized, open, two-period, double-crossover clinical study.
Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.