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BIOEQUIVALENCE STUDY OF 400 AND 100 MG IMATINIB FILM-COATED TABLETS IN HEALTHY VOLUNTEERS

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OSTROWICZ A., MIKOŁAJCZAK P. Ł., WIERZBICKA M., BOGURADZKI P.

Acta Poloniae Pharmaceutica - Drug Research

2014

vol. 71

issue 5

843-854

The aim of the study was to investigate the bioavailability of a generic product of 100 mg and 400 mg imatinib film-coated tablets (test) as compared to that of a branded product (reference) at the same strength to determine bioequivalence. The secondary objective of the study was to evaluate tolerability of both products. An open-label, randomized, crossover, two-period, single-dose, comparative study was conducted in 43 (Imatynib-Biofarm 100 mg film-coated tablet) and in 42 (Imatynib-Biofarm 400 mg film-coated tablet), brand name Imatenil, Caucasian healthy volunteers in fed conditions. A single oral dose administration of the test or reference product was separated by 14-day washout period. The imatinib and its metabolite N-desmethyl imatinib concentrations were determined using a validated LC MS/MS method. The results of the single-dose study in healthy volunteers indicated that the film-coated tablets of Imatynib-Biofarm 100 mg and 400 mg film-coated tablets manufactured by Biofarm Sp. z o.o. (test products) are bioequivalent to those of Glivec 100 mg and 400 mg film-coated tablets manufactured by Novartis Pharma GmbH (reference products). Both products in the two doses of imatinib were well tolerated.

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1 Acta Poloniae Pharmaceutica - Drug Research

1 2014

1 BOGURADZKI P.

1 MIKOŁAJCZAK P. Ł.

1 OSTROWICZ A.

1 WIERZBICKA M.

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BIOEQUIVALENCE STUDY OF 400 AND 100 MG IMATINIB FILM-COATED TABLETS IN HEALTHY VOLUNTEERS