NCT01355068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
7 months until next milestone

Results Posted

Study results publicly available

December 14, 2011

Completed
Last Updated

January 28, 2021

Status Verified

November 1, 2011

Enrollment Period

1 month

First QC Date

May 12, 2011

Results QC Date

November 10, 2011

Last Update Submit

January 26, 2021

Conditions

Healthy

Keywords

phenytoinchewable tabletsdilantinepanutininfatabsbioequivalencePartial seizureTonic-clonic seizure

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Treatment A

ACTIVE COMPARATOR

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

Drug: Epanutin Infatabs (Phenytoin)

Treatment B

EXPERIMENTAL

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

Drug: Dilantin Infatabs (Phenytoin)

Interventions

Epanutin Infatabs (Phenytoin)DRUG

Chewable Tablet, 50 mg, Single dose

Treatment A
Dilantin Infatabs (Phenytoin)DRUG

Chewable Tablet, 50 mg, Single dose

Treatment B

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Evidence or history of clinically significant abnormalities.
  • Any condition possibly affecting drug absorption (e.g. gastrectomy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

MeSH Terms

Conditions

Seizures

Interventions

Phenytoin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 17, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 28, 2021

Results First Posted

December 14, 2011

Record last verified: 2011-11

Locations

SG(1)