[Translation] Human bioequivalence of cefpodoxime axetil dry suspension in single-center, randomized, open-label, fasting and postprandial conditions, single-dose, two-cycle, two-sequence, self-cross-controlled in healthy adult subjects sex test
主要研究目的:以广州南新制药有限公司生产的头孢泊肟酯干混悬剂为受试制剂,以Aurobindo Pharma Ltd的头孢泊肟酯干混悬剂为参比制剂,按 NMPA 颁布的《药物临床试验质量管理规范》、《以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究技术指导原则》等要求开展本项研究,测定血浆中头孢泊肟的浓度,研究受试制剂与参比制剂的吸收速度和吸收程度,评价两制剂在空腹及餐后条件下单次给药时的生物等效性。
次要研究目的:观察两制剂在健康受试者中的安全性。
[Translation] Main research purposes: The cefpodoxime axetil dry suspension produced by Guangzhou Nanxin Pharmaceutical Co., Ltd. was used as the test preparation, and the cefpodoxime axetil dry suspension produced by Aurobindo Pharma Ltd was used as the reference preparation. This study is required to be carried out by the Quality Management Practice for Clinical Trials" and "Technical Guidelines for Human Bioequivalence Research of Chemical Drug Generic Drugs Using Pharmacokinetic Parameters as Endpoint Evaluation Indicators" to determine the concentration of cefpodoxime in plasma. The absorption rate and degree of absorption of the test preparation and the reference preparation were used to evaluate the bioequivalence of the two preparations in a single dose under fasting and postprandial conditions.
Secondary study objectives: To observe the safety of both formulations in healthy subjects.