[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period crossover bioequivalence study of cefditoren pivoxil granules in healthy Chinese adult subjects under fasting and fed conditions
主要研究目的:考察单次口服空腹和餐后状态下受试制剂头孢托仑匹酯颗粒和参比制剂头孢托仑匹酯颗粒,在中国成年健康受试者体内的药代动力学特征,评价空腹和餐后条件下分别口服两种制剂的生物等效性。
次要研究目的:评价受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] The main purpose of the study is to investigate the pharmacokinetic characteristics of the test preparation cefditoren pivoxil granules and the reference preparation cefditoren pivoxil granules in Chinese healthy adult subjects after a single oral administration under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations after oral administration under fasting and fed conditions.
Secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in Chinese healthy adult subjects.