A randomized, open label, multi-dose, two treatment, two-way crossover, steady state, bioequivalence study comparing Amneal Pharmaceuticals Felbamate 600 mg tablets to the Reference Listed Drug (RLD), Felbatol® (felbamate) 600 mg tablets Manufactured by MEDA Pharmaceuticals (formerly Medpointe) in adult male and non-pregnant female epilepsy patients under fasting condition

This is a randomized, open label, multi-dose, two treatment, two-way crossover, steady state, bioequivalence study to compare the bioavailability of Amneal Pharmaceuticals Felbamate 600 mg tablets (test) to the Reference Listed Drug Felbatol® (felbamate) 600 mg tablets in patients with epilepsy under fasting condition. 28 patients with refractory epilepsy, controlled and maintained on 1800 to 4800 mg/day doses of felbamate for at least two weeks prior to randomization will be eligible to enter the 14 day study period with no washout between the two periods. Repeated post-dose blood sampling will be done for evaluating the pharmacokinetic parameters in both the periods. The primary outcome measure is to establish bioequivalence of two fomulations on the basis of geometric means and 90% confidence intervals of the AUCss and Cmax ratio (test/reference)