Bioequivalency Study of Two Formulations of Ketoconazole Tablet in Healthy Volunteers

In this study, the pharmacokinetic parameters of two marketed tablet formulationsof ketoconazole were studied, and the relative bioavailability of the test formulationwas compared with a reference formulation. a single dose (12x2) double blindrandomized cross-over study of a generic formulation of ketoconazole tablet (2x200mg), and a commercial brand, nizoral tablet (2x200 mg, janssen pharmaceuticabeerse belgica) was carried out. all of the tablets met the united statespharmacopoeia dissolution specifications. the plasma level of ketoconazole wasdetermined by using a modified rapid and selective reverse phase hplc method.plasma data was used to evaluate the relative bioavailability and other pharmacokineticparameters characterizing rate [peak plasma concentration (cmax) and timeof peak concentration (tmax)] and the extent of absorption (auc). the mean peakplasma concentration (cmax) of ketoconazole of the two different formulations, a(reference) and b (test), were 7.08پ}2.81 and 6.74پ}2.20 mg/l at 1.70پ}0.48 h and1.73پ}0.75 h, respectively. the mean auc0. پ‡ of the two products, were 39.07پ}16.25and 31.85پ}14.64 for aand b, respectively. statistical analysis showed no significantd i fferences between various pharmacokinetic parameters of the two differentformulations. the 90%