昂利康阿莫西林胶囊启动生物等效性试验 适应症为敏感菌所致感染

Group 1 - The clinical trial for Amoxicillin capsules by Zhejiang Anglikang Pharmaceutical Co., Ltd. has been initiated, focusing on the bioequivalence study in healthy Chinese subjects [1] - The trial is designed as a single-center, open-label, randomized, single-dose, two-period, two-sequence, and crossover study, with a clinical trial registration number of CTR20255192 [1] - The primary objective is to evaluate the pharmacokinetics of the test formulation compared to the reference formulation under fasting conditions, while the secondary objective assesses the safety of both formulations [1] Group 2 - The trial's primary endpoints include Cmax, AUC0-t, AUC0-∞, vital signs, physical examinations, 12-lead ECG, clinical laboratory tests, and adverse events, evaluated 12 hours post-administration [2] - Secondary endpoints consist of Tmax, t1/2, λz, AUC_%Extrap, Vd/F, CL/F, F, along with the same safety assessments as primary endpoints, evaluated until the end of follow-up [2] - The current status of the trial is ongoing, with a target enrollment of 24 participants [3]