Bioequivalence study of a generic formulation of imatinib mesylate 400 mg filmcoated tablets versus Glivec® : a randomized open-label trial, single-dose, fasting, two-period, two-sequence crossover comparison in healthy Colombian volunteers.

Estudio de bioequivalencia de una formulación genérica de tabletas recubiertas de imatinib mesilato por 400 mg versus Glivec® : un estudio comparativo, aleatorizado, abierto, de dosis única, en ayunas, de dos períodos, en dos secuencias cruzadas en volunt

Published 2013-03-01

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Vol. 2 No. 1 (2013): Marzo
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Bioequivalence study of a generic formulation of imatinib mesylate 400 mg filmcoated tablets versus Glivec® : a randomized open-label trial, single-dose, fasting, two-period, two-sequence crossover comparison in healthy Colombian volunteers.
Rev. colomb. hematol. oncol. [Internet]. 2013 Mar. 1 [cited 2024 Dec. 22];2(1):15-21. Disponible en: https://doi.org/10.51643/22562915.327
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Mauricio Vargas
Universidad de La Sabana
    Carlos Bustamente
    Universidad de La Sabana
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      Mauricio Vargas,

      Unidad de Investigación Clínica y Farmacológica, Facultad de Medicina, Universidad de La Sabana (Bogotá, Colombia)

      Carlos Bustamente,

      Unidad de Investigación Clínica y Farmacológica, Facultad de Medicina, Universidad de La Sabana (Bogotá, Colombia).

      Objective: To compare bioavailability of two different imatinib pharmaceutical formulations to establish bioequivalency, according to FDA regulation. Methods: A single-dose, randomized open-label trial was performed, fasting, in two periods and two complete cross sequences with an 8-day washout period. All the study subjects were from Colombia. Imatinib blood levels were measured from plasma samples using high-efficiency liquid chromatography (HPLC) with an UV-light detector. Results: Healthy volunteers representative of Colombian population and racial types were included with a mean age of 25 years (range 18-40) and a mean body mass index (BMI) of 22 kg/m2 (range 19-24,9). Test product Cmax, Tmax and AUC (0-t) were 1437,2 ng/ml, 3,4 hours and 20431.5 ng.h/ml. Meanwhile reference product Cmax, Tmax and AUC Inf was 1435,9 ng/ml, 3,4 hours and 21296,5 ng.h/ml, respectively. Test/reference product ratios for Cmax, AUC (0-t) and AUC (0-inf) were 1,002 (CI 90% 0,903-1,112), 1,072 (CI 90% 0,935-1,230) and 1,029 (CI 90% 0,914-1,158), respectively. Conclusion: Test product (Imatin®, Procaps) and reference product (Glivec®, Novartis) are bioaquivalente according to FDA-established regulation.

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