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

An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Epanutin Infatabs 50 mg (Sourced From Germany) Verses Dilantin Infatabs 50 mg (Sourced From Australia) in Healthy Subjects

In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a pivotal bioequivalence study.

Inclusion Criteria:

• Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
• An informed consent document signed and dated by the subject.

Exclusion Criteria:

• Evidence or history of clinically significant abnormalities.
• Any condition possibly affecting drug absorption (e.g. gastrectomy).