drugset / Trial / NCT01355068

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

NCT01355068

Phase 1 Completed 26 enrolled Viatris Inc.
RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start
2011-05
Primary completion
2011-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Phenytoin Unknown 50 mg

Indications

No indication recorded.