Evaluation of bio-equivalence and bio availability of levetiracetam 1000 mg tablet with reference to standard 1000 mg tablet in normal male in human healthy volunteers

Abstract

This present study was designed on a treatise on open labeled randomized double blinded two period crossover
evaluations of bio-equivalence and bioavailability of levetiracetam 1000 mg tablet with reference to standard 1000mg
tablet in normal male healthy volunteers under fasting conditions. From the clinical data it can be concluded that the study
objectives like the safety and efficacy of the test product has been achieved. Based on clinical, pharmacokinetic and
statistical data obtained from 22 healthy, adult, male, human subjects under fasting conditions, it was concluded that a
single dose of test formulation „t‟ containing drug levetiracetam 1000mg was found to be safe and bioequivalent to the
reference formulation „r‟ (keppra 1000mg) containing levetiracetam 1000mg as 90 % confidence interval for the ratios of
means of test and reference parameters such as ln-transformed cmax, auc0-t and auc0- of drug levetiractam fell within the
bioequivalence acceptance range of 80.00% – 125.00 %. This study gave us insight that a levetiractam 1000mg tablet was
bioequivalent to keppra 1000mg in terms of rate and extent of absorption under fasting conditions.