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Bioequivalence study of 500 mg cefuroxime film-coated tablets in healthy volunteers

Michał Kaza 1Hanna Ksycińska 1Andrzej Leś 1,2Krystyna Serafin-Byczak 1Piotr J. Rudzki 1Piotr Gutkowski 3Tomasz Drewniak 3Anna Gutkowska 3Ewa Piątkowska-Chabuda 4Małgorzata Skowrońska-Smolak 4Ewa D. Wilkowska 4

1. Pharmaceutical Research Institute (IF), Rydygiera 8, Warszawa 01-793, Poland
2. Warsaw University Faculty of Chemistry, Warszawa 02-093, Poland
3. TRIAL Clinical Research, Warszawa 04-555, Poland
4. Tarchomin Pharmaceutical Works (TZF), Warszawa 03-176, Poland


Cefuroxime is a semisynthetic, broadspectrum cephalosporin antibiotic.
The aim of the study was to investigate the bioavailability of a generic formulation of 500-mg cefuroxime film-coated tablets (test) as compared to that of a branded formulation (reference) at the same strength to determine bioequivalence and to apply for regulatory approval.
A double blinded, randomized, crossover, two-period, single-dose, comparative study was conducted in healthy white volunteers in fasting conditions in compliance with the Good Clinical Practice principles. A single oral dose of the test or reference formulation was followed by 7-day wash-out period. Cefuroxime concentration was determined by validated HPLC-UV method [1] in compliance with the principles of Good Laboratory Practice. The formulations were considered bioequivalent if the 90% CI of the geometric mean ratios (test/reference) for AUC(0-t), AUC(0-∞) and Cmax were within the range 80.00 – 125.00% [2,3].
24 healthy male and female volunteers completed the study. There were no significant differences in pharmacokinetic parameters between formulations. The results of the study indicate that the 500 mg film-coated tablets of Tarsime manufactured by Tarchomińskie Zakłady Farmaceutyczne “Polfa” (test formulation) are bioequivalent to those of Zinnat manufactured by GlaxoSmithKline Export Ltd (reference formulation). Both formulations were well tolerated.
The study was supported by Tarchomińskie Zakłady Farmaceutyczne “Polfa”.

[1]    A. Szlagowska, M. Kaza, P. Rudzki: Validated HPLC method for determination of cefuroxime in human plasma, Acta Pol Pharm 67 (2010) 677-681.
[2]    Note for Guidance on the Investigation of Bioavailability and Bioequivalence. Committee for Proprietary Medicinal Products (CPMP/EWP/QWP/1401/98). London, 26 July 2001.
[3]    Guideline on the Investigation of Bioequivalence. Committee for Proprietary Products for Human Use (CPMP/EWP/QWP/1401/98/Rev. 1/Corr**). London, 20 January 2010.


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Submitted: 2012-04-13 11:58
Revised:   2012-04-16 07:26