[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, double-crossover bioequivalence study of oral STBW in Chinese healthy volunteers after fasting and feeding
主要研究目的
研究空腹和餐后状态下单次口服受试制剂头孢克肟干混悬剂(规格:0.8g(100mg/5ml),广东万泰科创药业有限公司提供)与参比制剂头孢克肟干混悬剂(规格:100mg/5ml,持证商:Sanofi-aventis France),在健康成年受试者体内的药代动力学,评价空腹和餐后口服两种制剂的生物等效性。
次要研究目的
评价中国健康受试者空腹和餐后状态下,单次口服头孢克肟干混悬剂受试制剂和参比制剂后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of a single oral dose of the test preparation of cefixime dry suspension (specification: 0.8g (100mg/5ml), provided by Guangdong Wantai Kechuang Pharmaceutical Co., Ltd.) and the reference preparation of cefixime dry suspension (specification: 100mg/5ml, licensee: Sanofi-aventis France) in healthy adult subjects under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations when taken orally on a fasting and fed basis.
Secondary study objectives
To evaluate the safety of a single oral dose of the test preparation and reference preparation of cefixime dry suspension in healthy Chinese subjects under fasting and fed conditions.