NCT01122940

Brief Summary

Mexican healthy volunteers will receive the current form of the drug (under the name of Epamin) as well as Pfizer's compound (Phenytoin). Bioequivalence will be tested.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2010

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

First Submitted

Initial submission to the registry

April 20, 2010

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2011

Enrollment Period

1 month

First QC Date

April 20, 2010

Last Update Submit

January 26, 2021

Conditions

Healthy

Keywords

BioequivalencePhenytoinEpamin

Outcome Measures

Primary Outcomes (1)

  • To prove the bioequivalence of Phenytoin versus Epamin by measuring; Area under the curve (AUC), Maximum Concentration (Cmax), Time maximum concentration (tmax), Constant of elimination (ke), Elimination half life (t1/2)

    April 2010 - May 2010

Study Arms (2)

Epamin: McNeil LA LLC

ACTIVE COMPARATOR
Drug: Epamin: Reference Drug

Phenytoin: Laboratorios Pfizer SA DE CV

EXPERIMENTAL
Drug: Phenytoin: Study Drug

Interventions

Epamin: Reference DrugDRUG

Single dose of 75 mg (10 ml in suspension) of Epamin

Epamin: McNeil LA LLC
Phenytoin: Study DrugDRUG

Single dose of 75 mg (10 ml in suspension) of Phenytoin

Phenytoin: Laboratorios Pfizer SA DE CV

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
  • A Body Mass Index (BMI) of 18 to 26.9 kg/m2 or ± 10% variation of the ideal weight; and a total body weight \>50 kg (110 lbs)
  • An informed consent document signed and dated by the subject or a legally acceptable representative.

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
  • Any condition possibly affecting drug absorption (eg, gastrectomy)
  • A positive urine drug screen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Mexico City, Mexico City, 14050, Mexico

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 20, 2010

First Posted

May 13, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

January 27, 2021

Record last verified: 2011-01

Locations

ME(1)