[Translation] A randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of cefdinir dry suspension in Chinese healthy volunteers on an empty stomach or after a meal
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] Main objectives:
1. To study the pharmacokinetic behavior of cefdinir in healthy Chinese subjects after a single oral administration of the test formulation of cefdinir dry suspension (specification: 250mg/5ml, provided by Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd.) and the reference formulation (specification: 250mg/5ml, licensee: Sandoz Inc.) on an empty stomach, and to evaluate the bioequivalence of the two formulations after oral administration on an empty stomach.
2. To study the pharmacokinetic behavior of cefdinir in healthy Chinese subjects after a single oral administration of the test formulation of cefdinir dry suspension (specification: 250mg/5ml, provided by Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd.) and the reference formulation (specification: 250mg/5ml, licensee: Sandoz Inc.) after a meal, and to evaluate the bioequivalence of the two formulations after oral administration on a empty stomach.
Secondary objectives:
To evaluate the safety of the test formulation and the reference formulation of cefdinir dry suspension in healthy Chinese subjects after a single oral administration on an empty stomach and after a meal.