[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, crossover bioequivalence study of linezolid dry suspension in healthy subjects under fasting conditions
主要目的:以石药集团中诺药业(石家庄)有限公司生产的利奈唑胺干混悬剂为受试制剂,以Pfizer Service Company BVBA生产的利奈唑胺干混悬剂(商品名:Zyvox®)为参比制剂,按生物等效性试验的相关规定,比较利奈唑胺干混悬剂在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:评价健康受试者单次空腹口服利奈唑胺干混悬剂受试制剂和参比制剂后的安全性。
[Translation] Main purpose: Using the linezolid dry suspension produced by Shijiazhuang Zhongnuo Pharmaceutical Co., Ltd. of Shijiazhuang Pharmaceutical Group as the test preparation and the linezolid dry suspension produced by Pfizer Service Company BVBA (trade name: Zyvox®) as the reference preparation, the pharmacokinetic behavior of the linezolid dry suspension in healthy subjects was compared according to the relevant provisions of the bioequivalence test, and the bioequivalence of the two preparations was evaluated.
Secondary purpose: To evaluate the safety of the linezolid dry suspension test preparation and the reference preparation after a single oral administration on an empty stomach in healthy subjects.