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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

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.

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)

Eligibility

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

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).

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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