Comparative bioavailability study with two sodium valproate tablet formulations administered under fasting conditions in healthy subjects.

Autor: Mendes GD, Lotufo CC, Bosio-Guimarães RA, de Castro HA, Babadopulos T, Ribas Freitas AR, Antunes NJ, Nucci G
Jazyk: angličtina
Zdroj: International journal of clinical pharmacology and therapeutics [Int J Clin Pharmacol Ther] 2022 May; Vol. 60 (5), pp. 232-241.
DOI: 10.5414/CP203961
Abstrakt: Aim: To assess the bioequivalence of two sodium valproate formulations in healthy subjects of both sexes.
Materials and Methods: The study was conducted using an open, randomized, two-period crossover design with a 2-week washout interval. Plasma samples were obtained over a 96-hour period. Plasma concentrations of valproate were analyzed by liquid chromatography coupled to tandem mass spectrometry (LC/MS) with negative ion electrospray ionization. From the sodium valproate plasma concentration vs. time curves, the following pharmacokinetic parameters were obtained C max , AUC, t max , Ke, and T 1/2 .
Results: The geometric mean with corresponding 90% confidence interval for test/reference percent ratios were 104.43% (90% CI 100.42 - 108.61%) for C max , 98.11% (90% CI = 94.66 - 101.70%) for AUC last , and 96.71% (90% CI = 92.97 - 100.60%) for AUC 0-inf .
Conclusion: Since the 90% CI for C max and AUC last ratios were all inside the 80 - 125% interval proposed by the US Food and Drug Administration Agency (FDA), it was concluded that the new sodium valproate formulation (epilenil 500-mg coated tablet) without food elaborated by Biolab Sanus Farmaceutica Ltda is bioequivalent to depakene formulation for both the rate and the extent of absorption.
Databáze: MEDLINE
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