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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355068
• Other study ID #: A4121010
• Status: Completed
• Phase: Phase 1
• Start date: May 2011
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Epanutin Infatabs (Phenytoin)
Chewable Tablet, 50 mg, Single dose
• Dilantin Infatabs (Phenytoin)
Chewable Tablet, 50 mg, Single dose

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).	0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dose
Primary	Maximum Observed Plasma Concentration (Cmax)		0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-8])	AUC (0-8) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-8). It is obtained from AUC (0-t) plus AUC (t-8).	0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Secondary	Extrapolated Area Under the Curve (AUC Percent [%] Extrap)	AUC%extrap is the percentage of AUC [0-8] obtained by forward extrapolation. It is calculated as (AUC [0-8] minus AUClast)*100/ AUC [0-8], where AUC [0-8] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-8) and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.	0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Secondary	Plasma Decay Half Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose

External Links

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