[Translation] Evaluation of cefditoren pivoxil granules in a single-center, randomized, open-label, fasting and fed conditions single-dose, two-drug, two-period crossover bioequivalence study in Chinese adult healthy subjects
主要研究目的:
考察单次口服(空腹和餐后)受试制剂头孢托仑匹酯颗粒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,评估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单次口服50 mg(空腹和餐后)在中国成年健康受试者中的安全性。
[Translation] Main research purposes:
Investigate the pharmacokinetic characteristics of a single oral (fasting and postprandial) test preparation cefditoren pivoxil granules and reference preparation cefditoren pivoxil granules in Chinese adult healthy subjects, and evaluate fasting and postprandial conditions The bioequivalence of the two preparations were administered orally.
Secondary research purposes:
To evaluate the safety of a single oral administration of 50 mg of the test preparation and the reference preparation (on an empty stomach and after meals) in Chinese adult healthy subjects.