title: Bioequivalence study of 500 mg cefuroxime axetil film-coated tablets in healthy volunteers.
abstract: The aim of the study was to investigate the bioavailability of a generic product of 500 mg cefuroxime axetil film-coated tablets (test) as compared to that of a branded product (reference) at the same strength to determine bioequivalence and to apply for regulatory approval. The secondary objective of the study was to evaluate tolerability of both products. A double blinded, randomized, crossover, two-period, single-dose, comparative study was conducted in Caucasian healthy volunteers in fasting conditions. A single oral dose administration of the test or reference product was followed by 7-day wash-out period. The cefuroxime concentration was determined using a validated HPLC-UV method. The results of the single-dose study in healthy volunteers indicated that the film-coated tablets of Tarsime 500 mg manufactured by Tarchomińskie Zakłady Farmaceutyczne Polfa S.A. (test product) are bioequivalent to those of Zinnat manufactured by GlaxoSmithKline Export Ltd. (reference product). Both products were well tolerated.
authors.affiliation: Pharmaceutical Research Institute, Pharmacology Department, Warszawa, Poland. m.kaza@ifarm.eu
authors.forename: Michał
authors.initials: M
authors.lastname: Kaza
authors.forename: Andrzej
authors.initials: A
authors.lastname: Leś
authors.forename: Krystyna
authors.initials: K
authors.lastname: Serafin-Byczak
authors.forename: Hanna
authors.initials: H
authors.lastname: Ksycińska
authors.forename: Piotr J
authors.initials: PJ
authors.lastname: Rudzki
authors.forename: Piotr
authors.initials: P
authors.lastname: Gutkowskpi
authors.forename: Tomasz
authors.initials: T
authors.lastname: Drewniak
authors.forename: Anna
authors.initials: A
authors.lastname: Gutkowska
authors.forename: Andrzej
authors.initials: A
authors.lastname: Tarasiuk
authors.forename: Ewa
authors.initials: E
authors.lastname: Piatkowska-Chabuda
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Skowrońska-Smolak
authors.forename: Ewa
authors.initials: E
authors.lastname: Wilkowska
mesh_terms: D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics*; D002444:Cefuroxime / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency
chemical_list: D000900:Anti-Bacterial Agents; D013607:Tablets; D002444:Cefuroxime; C040738:cefuroxime axetil