生物等效性和生物利用度杂志

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Bioequivalence of Two Oral Formulations of Modafinil Tablets in Healthy Male Subjects under Fed and Fasting Conditions

AlSayed Sallam, Isam I. Salem, Dalia AlJohari, Mohannad Shawer, Bilal Abu Alaasal and Derar Omari

Modafinil is a novel wake-promoting agent for oral administration. The aim of this study was to determine bioequivalence of two tablet formulations: Hikma Modafinil 200 mg tablets relative to the originator Provigil® 200 mg tablets after oral administration to healthy subjects under both fed and fasting conditions. Twenty eight subjects, in either fed and fast studies, were enrolled and completed the crossover. The method was designed as open-label, randomized two-way crossover study with a 7-day washout period for each study. Pharmacokinetic parameters of modafinil were estimated using standard non-compartmental methods. The Cmax, Tmax, AUC0-t and AUC0-∞ were calculated. The results of this bioequivalence study showed the equivalence of the two studied products in terms of the rate of absorption as indicated by Cmax and in terms of the extent of absorption as indicated by AUC0-t and AUC0- ∞. The parametric 90% confidence intervals of the mean values for the Test/Reference ratio were in each case well within the bioequivalence acceptable boundaries of 80.00 – 125.00 % for the pharmacokinetic parameters AUC0-t, AUC0-∞ and Cmax. The effect of food is obvious where the Cmax and AUC are lower in the fed study compared with fasting.