UDC 615.2 CONTEMPORARY EVIDENCE BASED MEDICINE: THE RESULTS OF BIOEQUIVALENCE RESEARCH OF MEDICINES «INSPIRON» AND «ERESPAL» I.А.Zupanets, Yu.V.Podpruzhnikov, N.P.Bezugla, I.O.Gaivo­ronska, I.M.Khil

The research results in studying bioequivalence of medicines containing fenspiride – Inspiron coated tablets, 80 mg, manufactured by «Kievmedpreparat» JSC (Ukraine) and Erespal coated tablets, 80 mg manufactured by «Les Laboratories Servier» (France) are presented. 24 healthy male and female volunteers took part in the clinical trial. The limits of 90% CI for the ratio of geometric mean basic pharmacokinetic parameters of Сmax and AUC0-t have been determined, and they are 109.25-122.99% and 106.37-118.46%, respectively. Based on the results of analysis for Сmax and AUC0-t, the conclusion can be made that Inspiron medicine manufactured by «Kievmedpreparat» JSC (Ukraine) is bioequivalent to Erespal manufactured by «Les Laboratories Servier» (France) when administered orally as a single dose by fasting healthy volunteers. In relation to evidence based medicine the medicines Inspiron and Erespal are substitutes.

Key words: bioequivalence, Inspiron, Erespal, fenspiride

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