چكيده لاتين :
In this study, the pharmacokinetic parameters of two marketed tablet formulations
of ketoconazole were studied, and the relative bioavailability of the test formulation
was compared with a reference formulation. A single dose (12x2) double blind
randomized cross-over study of a generic formulation of ketoconazole tablet (2x200
mg), and a commercial brand, Nizoral tablet (2x200 mg, Janssen Pharmaceutica
Beerse Belgica) was carried out. All of the tablets met the United States
Pharmacopoeia dissolution specifications. The plasma level of ketoconazole was
determined by using a modified rapid and selective reverse phase HPLC method.
Plasma data was used to evaluate the relative bioavailability and other pharmacokinetic
parameters characterizing rate [peak plasma concentration (Cmax) and time
of peak concentration (Tmax)] and the extent of absorption (AUC). The mean peak
plasma 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 and
1.73پ}0.75 h, respectively. The mean AUC0. پ‡ of the two products, were 39.07پ}16.25
and 31.85پ}14.64 for Aand B, respectively. Statistical analysis showed no significant
d i fferences between various pharmacokinetic parameters of the two different
formulations. The 90%
