Abstract
The bioequivalence of two medicinal products, containing combination of amoxicillin and clavulanic acid, Amoxil-K 1000, film-coated tablets 875 mg/125 mg, manufactured by Kyivmedpreparat JSC (Ukraine), and AUGMENTIN™ (BD), film-coated tablets 875 mg/125 mg, manufactured by «SmithKline Beecham Pharmaceuticals» (Great Britain), was demonstrated by means of pharmacokinetic studies. The test product and the reference product were administered to healthy volunteers as a single oral dose of 875 mg of amoxicillin/125 mg of clavulanic acid. Blood samples were taken during 10 hour period. Washout period was 7 days. Plasma concentrations of amoxicillin and clavulanic acid were determined by the method of ultraeffective liquid chromatography with tandem mass-selective detection. 90% confidence interval limits for Сmax и AUC0-t of test and reference products were 94.70%÷106.38% and 96.05%÷104.46% for amoxicillin, 86.67%÷118.13% and 86.48%÷119.85% for clavulanic acid, respectively. Adverse reactions/effects (AR/AE) were observed in 4 (7.7%) volunteers after administration of the reference medicinal product, and were qualified as non-serious and mild. The obtained results demonstrated proved bioequivalence and and good safety of the test and reference medicinal products.
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