Bioequivalence between two commercial formulations of gliclazide in Colombia
DOI:
https://doi.org/10.17533/udea.iatreia.3789Keywords:
Gliclazide, Chromatography, BioequivalenceAbstract
Two commercial formulations of Gliclazide 80 mg tablets were studied in order to evaluate both pharmaceutical and biological equivalence, Glidiab® Tecnoquímicas Laboratories and Diamicron® Euroetika-Elsevier Laboratories.
After proving the pharmaceutical equivalence, a bioequivalence was tested in 14 healthy volunteers and the determination of gliclazide in plasma was carried out by high-performance liquid chromatography (HPLC). The evaluated pharmacokinetic parameters were: area under the curve (AUC) from 0 to 60 hours, maximum concentration (Cmax) and time to maximum concentration (Tmax). In statistical analysis the 90.0% confidence intervals for AUC, Cmax and Tmax, and acceptance range for bioequivalence of 80.0%-125.0% to AUC and Cmax and acceptance range of 80:0%-120.0% to Tmax, were applied.
Both formulations presented inter and intra subject high variability and it was found that they are bioequivalent in relation to AUC but they are not bioequivalent in relation to Cmax and Tmax.
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