Lack of pharmacokinetic bioequivalence between generic and branded amoxicillin formulations. A post-marketing clinical study on healthy volunteers

摘要

AIMS:There are concerns about the quality of generic drugs in the postmarketing setting.The aim was to establish whether two generic formulations of amoxicillin, available on the Italian market, fulfil the criteria for clinical pharmacokinetic bioequivalence vs. the branded drug.METHODS:Two generic amoxicillin products (generic A and B) were selected among four fast-release tablet formulations available on the Italian market.Twenty-four healthy adult volunteers of either sex participated to a single-dose, randomized, three-treatment, crossover, single-blind bioequivalence study designed to compare generic A and B with branded amoxicillin. Plasma samples were collected at preset times for 24 h after dosing, and assayed for amoxiciilin levels by high-performance liquid chromatography.