Bioequivalence of two oral formulations of nitazoxanide in healthy volunteers

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DOI:

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

Abstract

Objective: This study evaluated the bioequivalence (BE) between two Nitazoxanide 20mg/ml oral suspension formulations. Methods: We carried out a single-center, open-label, randomized, single-dose, two-sequence, two-period. Subjects received single oral doses of 500 mg Nitazoxanide oral suspension. Whole blood samples were collected pre-dose and at specified intervals up to 12 h post-dose to assess pharmacokinetic parameters. Results: Thirty healthy adult subjects completed the study. We found the 90% confidence intervals for the geometric mean ratios for the Tixozanide area under the curve AUC0‐t and AUC0‐∞ and maximum plasma concentration (Cmax) were within the established limits of 80% to 125 % of BE. Conclusion: The criteria for BE were met for the nitazoxanide formulations from Eurofarma Laboratórios S.A.

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Published

2024-09-24

How to Cite

1.
REZENDE VM, SVERDLOFF C, GUIMARÃES CL, SCHRAMM SG, AIHARA CK, XAVIER KI, PACHECO FB. Bioequivalence of two oral formulations of nitazoxanide in healthy volunteers. Rev Bras Farm Hosp Serv Saude [Internet]. 2024Sep.24 [cited 2024Dec.11];15(3):e1106. Available from: https://www.rbfhss.org.br/sbrafh/article/view/1106

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