alexa Bioequivalence of Two Oral Formulations of Modafinil Tablets in Healthy Male Subjects under Fed and Fasting Conditions | OMICS International
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Journal of Bioequivalence & Bioavailability
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Research Article

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

AlSayed Sallam1, Isam I. Salem2, Dalia AlJohari3, Mohannad Shawer4, Bilal Abu Alaasal4and Derar Omari5*

1STD, The Specialized Pharmaceutical Research Co., Amman, Jordan (present address at Al-Taqaddom Pharmaceutical Industries co. Amman, Jordan)

2IPRC International Pharmaceutical Research Center (IPRC), Amman, Jordan

3Hikma Pharmaceuticals PLC, Amman, Jordan

4STD The specialized Pharmaceutical Research Co., Amman, Jordan, (present address: Bosch and Lomb Co., Rochester, NY, USA)

5STD, The specialized Pharmaceutical Research Co., Amman, Jordan, (present address: College of Pharmacy, Yarmouk University, Irbid, Jordan)

*Corresponding Author:
Omari D, STD
The specialized Pharmaceutical Research Co.
Amman, Jordan
Tel: 962 79 5013327
E-mail: [email protected]

Received Date: December 05, 2014; Accepted Date: January 18, 2014; Published Date: January 22, 2015

Citation: Sallam A, Salem II, AlJohari D, Shawer M, Alaasal BA, et al. (2015) Bioequivalence of Two Oral Formulations of Modafinil Tablets in Healthy Male Subjects under Fed and Fasting Conditions. J Bioequiv Availab 7:063-067. doi: 10.4172/jbb.1000216

Copyright: ©2015 Sallam A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

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.

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