Bioequivalence of two oral formulations of nitazoxanide in healthy volunteers

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.