Bioequivalence evaluation of two brands of ketoconazole tablets (Onofin-K® and Nizoral®) in a healthy female Mexican population

Abstract

A randomized, crossover study was conducted in 24 healthy female volunteers to compare the bioavailability of two brands of ketoconazole (200 mg) tablets; Onofin-K® (Farmacéuticos Rayere S.A., México) as the test and NIZORAL® (Janssen-Cilag, Mé xico) as the reference products. The study was performed at the Clinical Pharmacology Research Center of the Hospital General de México in Mexico City. Two tablets (400 mg) were administered as a single dose with 250 ml of water after a 12 h overnight fast on two treatment days separated by a 1 week washout period. After dosing, serial blood samples were collected for a period of 12 h. Plasma harvested was analysed for ketoconazole by a modified and validated HPLC method with UV detection in the range 400-14000 ng/ml, using 200 μl of plasma in a full-run time of 2.5 min. The pharmacokinetic parameters AUC0-t, AUC0-α, Cmax, Tmax and t1/2 were determined from plasma concentrations of both formulations and the results discussed. AUC0-t, AUC0-α, and Cmax were tested for bioequivalence after log transformation of data, and no significant differences were found either in 90% classic confidence interval or in the Anderson and Hauck test (p<0.05). Based on statistical analysis, it is concluded that Onofin-K® is bioequivalent to Nizoral®. Copyright © 2004 John Wiley & Sons, Ltd.