Journal of Pharmacology and Pharmacotherapeutics

RESEARCH PAPER
Year
: 2013  |  Volume : 4  |  Issue : 4  |  Page : 243--246

Three-way, three-period, crossover bioequivalence study of single oral dose of three brands of 300 mg phenytoin sodium tablets marketed in India, on healthy Indian human volunteers


Maulik S Doshi1, Anuja A Naik2, Mohit R Mehta2, Nithya J Gogtay1, Urmila M Thatte1, Mala D Menon2 
1 Department of Clinical Pharmacology, Seth G S Medical College and KEM Hospital, Mumbai, India
2 Department of Pharmaceutics, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, India

Correspondence Address:
Mala D Menon
Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai - 400 098
India

Objective: To compare the bioavailability of two brands of phenytoin sodium tablets available in the Indian market using Eptoin TM as the reference. Materials and Methods: A randomized, assessor-blind, three-way crossover design study was carried out over a period of 6 months after approval from the Institutional Review Board (IRB). Twenty-two healthy male participants received a single oral 300 mg oral tablet of either of the formulations with a 2-week washout. Blood samples were collected predose and at regular intervals postdose. Plasma phenytoin levels were estimated by high-performance liquid chromatography. Calculation of C max , AUC 0-t , and AUC 0-∞ was done by the linear trapezoidal rule and 90-110% margin (90% confidence interval (CI)) was used to assess bioequivalence. Results: Twenty volunteers completed the study. It was seen that the log-transformed values of C max , AUC 0-t , and AUC 0-∞ of the test formulations were not within the specified limits. Conclusion: Bioinequivalence of available phenytoin brands indicates that switching brands could lead to variations in blood concentrations and thus impact safety and efficacy. If a brand switch is done for any reason, stringent drug-level monitoring is advised.


How to cite this article:
Doshi MS, Naik AA, Mehta MR, Gogtay NJ, Thatte UM, Menon MD. Three-way, three-period, crossover bioequivalence study of single oral dose of three brands of 300 mg phenytoin sodium tablets marketed in India, on healthy Indian human volunteers.J Pharmacol Pharmacother 2013;4:243-246


How to cite this URL:
Doshi MS, Naik AA, Mehta MR, Gogtay NJ, Thatte UM, Menon MD. Three-way, three-period, crossover bioequivalence study of single oral dose of three brands of 300 mg phenytoin sodium tablets marketed in India, on healthy Indian human volunteers. J Pharmacol Pharmacother [serial online] 2013 [cited 2020 Jun 4 ];4:243-246
Available from: http://www.jpharmacol.com/article.asp?issn=0976-500X;year=2013;volume=4;issue=4;spage=243;epage=246;aulast=Doshi;type=0