[Translation] A randomized, open-label, double-sequence, two-period, double-crossover design bioequivalence trial of cefdinir dry suspension in Chinese healthy subjects with fasting and postprandial single oral administration
主要目的:
1.研究空腹单次口服头孢地尼干混悬剂受试制剂(规格:250mg/5ml,广东金城金素制药有限公司提供)与参比制剂(规格:250mg/5ml,持证商:Sandoz Inc.)后头孢地尼在中国健康受试者体内的药代动力学行为,评价空腹口服两种制剂的生物等效性。
2.研究餐后单次口服头孢地尼干混悬剂受试制剂(规格:250mg/5ml,广东金城金素制药有限公司提供)与参比制剂(规格:250mg/5ml,持证商:Sandoz Inc.)后头孢地尼在中国健康受试者体内的药代动力学行为,评价餐后口服两种制剂的生物等效性。
次要目的:
评价中国健康受试者空腹和餐后单次口服头孢地尼干混悬剂受试制剂和参比制剂后的安全性。
[Translation] the main purpose:
1. Study the test preparation (specification: 250mg/5ml, provided by Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd.) and the reference preparation (specification: 250mg/5ml, certificate holder: Sandoz Inc) of single oral cefdinir dry suspension on an empty stomach .) Pharmacokinetic behavior of post-cefdinir in Chinese healthy subjects, evaluating the bioequivalence of the two formulations administered orally on an empty stomach.
2. Study the test preparation (specification: 250mg/5ml, provided by Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd.) and the reference preparation (specification: 250mg/5ml, certificate holder: Sandoz) after a single oral administration of cefdinir dry suspension Inc.), the pharmacokinetic behavior of cefdinir in Chinese healthy subjects, and the bioequivalence of the two preparations after meals were evaluated.
Secondary purpose:
To evaluate the safety of Chinese healthy subjects after a single oral administration of cefdinir dry suspension test preparation and reference preparation on an empty stomach and after a meal.