Conditions: Healthy
Keywords: phenytoin chewable tablets dilantin epanutin infatabs bioequivalence Partial seizure Tonic-clonic seizure
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 26
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: Epanutin Infatabs 50 mg (sourced from Germany), 1 x 50 mg (REFERENCE) arm 2: Dilantin Infatabs 50 mg (sourced from Australia), 1 x 50 mg (TEST)

Interventions: intervention 1: Epanutin Infatabs (Phenytoin) intervention 2: Dilantin Infatabs (Phenytoin)
Intervention descriptions: intervention 1: Chewable Tablet, 50 mg, Single dose intervention 2: Chewable Tablet, 50 mg, Single dose

Protocol document: