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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

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

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Maximum Observed Plasma Concentration (Cmax)

Secondary outcome:

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-Ôł×])

Extrapolated Area Under the Curve (AUC Percent [%] Extrap)

Plasma Decay Half Life (t1/2)

Time to Reach Maximum Observed Plasma Concentration (Tmax)


Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.


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).

Locations and Contacts

Pfizer Investigational Site, Singapore 188770, Singapore
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2011
Last updated: November 10, 2011

Page last updated: August 23, 2015

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