Bioequivalence of two oral formulations of nitazoxanide in healthy volunteers

Vinícius Marcondes  REZENDE; Carlos  SVERDLOFF; Camila Leles  GUIMARÃES; Simone Grigoleto  SCHRAMM; Camila Kaori  AIHARA; Kamila Iorgatchof  XAVIER; Fernando Bastos  PACHECO

doi:10.30968/rbfhss.2024.153.1106

Autores

Vinícius Marcondes REZENDE http://orcid.org/0000-0002-6586-0496
Carlos SVERDLOFF https://orcid.org/0000-0001-8676-5431
Camila Leles GUIMARÃES https://orcid.org/0000-0002-0116-2517
Simone Grigoleto SCHRAMM https://orcid.org/0000-0003-2248-0706
Camila Kaori AIHARA https://orcid.org/0000-0002-7754-8950
Kamila Iorgatchof XAVIER http://orcid.org/0000-0003-0620-1666
Fernando Bastos PACHECO http://orcid.org/0000-0001-9383-3244

DOI:

https://doi.org/10.30968/rbfhss.2024.153.1106

Resumo

Objetivo: Este estudo avaliou a bioequivalência (BE) entre duas formulações de suspensão oral de nitazoxanida 20mg/ml. Metodologia: Foi realizado um estudo monocêntrico, aberto, randomizado, de dose única, de duas sequências e de dois períodos. Os indivíduos receberam doses orais únicas de 500 mg de suspensão oral de nitazoxanida. Foram colhidas amostras de sangue total antes da dose e em intervalos especificados até 12 horas após a dose para avaliar os parâmetros farmacocinéticos. Resultados: Trinta indivíduos adultos saudáveis completaram o estudo. Os intervalos de confiança de 90% para as relações das médias geométricas para a área sob a curva da tixozanida AUC0-t e AUC0-∞ e concentração plasmática máxima (Cmax) estavam dentro dos limites estabelecidos de 80% a 125% de BE. Conclusão: Os critérios para BE foram cumpridos para as formulações de teste de nitazoxanida 20mg/ml da Eurofarma Laboratórios S.A.

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