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

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
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0976-500X.119709

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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.

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