الملخص

Introduction: Although amoxicillin has been widely prescribed in clinical practice for decades, recent studies have shown that it is still a very active bactericidal antibiotic that is more effective than other oral beta-lactam antibiotics. Numerous preparations containing amoxicillin are available on the market. The objective of this study was to compare the pharmacokinetic profiles and to evaluate the bioequivalence of two amoxicillin formulations, in 24 adult healthy volunteers. The test drug Shamoxil® (500 mg amoxicillin capsules) from Shaphaco was compared with a commercial Amoxil capsule (500 mg amoxicillin) formulation produced by SmithKline Beecham as the reference standard. Methods: Twenty-four male adult volunteers, non-smokers, aged between 21 and 47 years, weighing between 55 and 72 kg with an average height of 160 to 175 cm, were selected for the study. Four weeks prior to the beginning of the study, medical histories, physical examinations and laboratory screenings were conducted on all the volunteers. The study had an open randomized two-period crossover design with a 1-week washout period between doses. The analyses were performed on a Waters HPLC system (Waters, USA) equipped with a LC-10 AD VP pump, an SPD-10 A VP UV detector and an SCL 10 A- VP controller unit. The mobile phase consisted of a 95% phosphate buffer (0.01 mol/L), pH=3.2 and 5% acetonitrile mixture. The bioequivalence between the two formulations was assessed by calculating individual peak plasma concentrations (Cmax), (Tmax) area under the curve (AUCo-t), AUC0-0, T1/2, elimination rate constant (K) and ratios (test/reference) using the Kinetica software program (trapezoidal method). Cmax, AUC0-8h, AUC0-00, T1/2 and elimination rate constant (K) data were analyzed statistically using both parametric (one- way ANOVA) and non-parametric methods (Wilcoxon’s signed ranks test) using SPSS software program.

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