The present work aimed to compare the relative bioavailability of Zolapin with 100 mg tablet Leponex as\na reference formulation, through a simple, robust and low-cost bioequivalence assays method. The\nstudy design was multiple-dose, randomized, crossover with patients in steady-state, and was\nperformed with 24 schizophrenic male patients. Subjects received 100 mg twice a day of either Leponex\nor Zolapin for 10 days. At day 10 days of each study phase, blood samples were collected at different\ntimes during 12 h after drug administration and the clozapine concentration was determined by high\nperformance liquid chromatography (HPLC). The individual peak plasma concentrations (Cmax) and the\narea under the concentration-time curve (AUC0-12h) ratios were calculated. The evaluated\npharmacokinetic parameters were quite similar for both formulations. The 90% confidence interval for\nmean ratio of lnCmax (0.9677 to 0.9937) and lnAUC0-12h (0.9811 to 1.0029) were within accepted\ninternational guidelines. The results demonstrate that this methodological approach was able to\nidentify Zolapin as bioequivalent to Leponex when orally administered, both in terms of the rate and\nextent of absorption, and therefore, suitable as a potential low-cost alternative to branded antipsychotic\ndrugs.
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