A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).

Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose

Extrapolated Area Under the Curve (AUC Percent [%] Extrap)

AUC%extrap is the percentage of AUC \[0-∞\] obtained by forward extrapolation. It is calculated as (AUC \[0-∞\] minus AUClast)\*100/ AUC \[0-∞\], where AUC \[0-∞\] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.

Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose

Plasma Decay Half Life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose