Journal of Bioequivalence & Bioavailability

AlSayed Sallam

Publications

• Research Article
  Bioequivalence of Two Oral Formulations of Modafinil Tablets in Healthy Male Subjects under Fed and Fasting Conditions
  Author(s): AlSayed Sallam, Isam I. Salem, Dalia AlJohari, Mohannad Shawer, Bilal Abu Alaasal and Derar OmariAlSayed 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 A.. View More»
  DOI: 10.4172/jbb.1000216

  Abstract PDF