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

Author(s): Marcelin-Jimenez G, Hernandez J, Angeles AP, Contreras L, Hinojosa M, Rivera L, Martinez-Rossier L, Amancio O, Fernandez A

Affiliation(s): Servicio de Investigacion de Farmacologia Clinica, Hospital General de Mexico, Mexico City, Mexico. gabmarcelin@hotmail.com

Publication date & source: 2004-07, Biopharm Drug Dispos., 25(5):203-9.

Publication type: Clinical Trial; Randomized Controlled Trial

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 (Farmaceuticos Rayere S.A., Mexico) as the test and Nizoral (Janssen-Cilag, Mexico) as the reference products. The study was performed at the Clinical Pharmacology Research Center of the Hospital General de Mexico 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 microl of plasma in a full-run time of 2.5 min. The pharmacokinetic parameters AUC(0-t), AUC(0-alpha), Cmax, Tmax and t(1/2) were determined from plasma concentrations of both formulations and the results discussed. AUC(0-t), AUC(0-alpha) 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.