Ondansetron is a selective 5-HT₃ receptor antagonist administered as an antiemetic during chemotherapy and radiotherapy.

The aim of the study was to investigate the bioavailability of a generic product of 8 mg ondansetron film-coated tablets (test) as compared to that of a branded product (reference) at the same strength to prove 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 product was followed by 7-day wash-out period. Ondansetron concentration was determined by validated HPLC-UV method in compliance with the Good Laboratory Practice. The products 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% [1,2].

20 healthy male and female volunteers completed the study. There were no significant differences in pharmacokinetic parameters between products. The results of the study indicate that Ondatron 8 mg film-coated tablets manufactured by Tarchomińskie Zakłady Farmaceutyczne Polfa S.A. (test product) are bioequivalent to Zofran 8 mg film-coated tablets manufactured by GlaxoSmithKline Export Ltd (reference product). Both products were well tolerated [3].

The study was supported by Tarchomińskie Zakłady Farmaceutyczne Polfa S.A.

[1] Note for Guidance on the Investigation of Bioavailability and Bioequivalence. Committee for Proprietary Medicinal Products (CPMP/EWP/QWP/1401/98). London, 26 July 2001.

[2] 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.

[3]  P. J. Rudzki, M. Kaza, A. Leś, E. Gilant, H. Ksycińska, K. Serafin-Byczak, M. Troć, J. Raszek, E. Piątkowska-Chabuda, M. Skowrońska-Smolak, A. Tarasiuk, E. Wilkowska, T. Łazowski. Bioequivalence Study of 8 mg Ondansetron Film-coated Tablets in Healthy Caucasian Volunteers. DrugRes - accepted for publication

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