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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Epanutin Infatabs (Phenytoin); Drug: Dilantin Infatabs (Phenytoin)

• Registration Number: NCT01355068
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-11
• Results First Submitted: 2011-11-10
• Results First Submitted QC: 2011-11-10
• Results First Posted: 2011-12-14
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Epanutin Infatabs (Phenytoin)	Epanutin Infatabs 50 mg (sourced from Germany), 1 x 50 mg (REFERENCE)
Treatment B	Dilantin Infatabs (Phenytoin)	Dilantin Infatabs 50 mg (sourced from Australia), 1 x 50 mg (TEST)

Primary Outcome Measures

Name	Time	Method
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
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dose	Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore