[Translation] A single-center, randomized, open-label, two-drug, two-cycle, two-sequence crossover bioequivalence study of cefixime tablets in healthy volunteers under fasting conditions
主要研究目的:健康受试者空腹状态下口服单剂量头孢克肟片后,观察头孢克肟在体内药代动力学过程,估算相应的药代动力学参数,进行生物等效性评价。 次要研究目的:观察受试制剂头孢克肟片和参比制剂头孢克肟片(Suprax)在健康受试者中的安全性。
[Translation] The main purpose of the study was to observe the pharmacokinetic process of cefixime in vivo, estimate the corresponding pharmacokinetic parameters, and evaluate the bioequivalence of the test preparation cefixime tablets and the reference preparation cefixime tablets (Suprax) in healthy subjects after oral administration of a single dose of cefixime tablets in the fasting state. The secondary purpose of the study was to observe the safety of the test preparation cefixime tablets and the reference preparation cefixime tablets (Suprax) in healthy subjects.