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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Phenytoin

Criteria

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).