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

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Epanutin Infatabs (Phenytoin); Drug: Dilantin Infatabs (Phenytoin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01355068

A4121010

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Treatment A

Active Comparator group

Description:

Epanutin Infatabs 50 mg (sourced from Germany), 1 x 50 mg (REFERENCE)

Treatment:

Drug: Epanutin Infatabs (Phenytoin)

Treatment B

Experimental group

Description:

Dilantin Infatabs 50 mg (sourced from Australia), 1 x 50 mg (TEST)

Treatment:

Drug: Dilantin Infatabs (Phenytoin)