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CompletedNCT01122953Updated Jan 27, 2021

Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions

A Phase 1 interventional study of Phenytoin and Epamin in Healthy, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 1 site in Mexico. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

To investigate the bioequivalence between two compounds (phenytoin and epamin) by a randomized, single dose study under fasting conditions in healthy volunteers.

Read the detailed description

Bioequivalence study in healthy volunteers

02

Conditions studied

  • Healthy

Keywords

  • Bioequivalence
  • EPAMIN
  • PHENYTOIN
03

In context

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male and/or female subjects between the ages of 18 and 55 years
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Phenytoin

    Drug: Phenytoin

  • Active comparator
    Epamin

    Drug: Epamin

Interventions

  • DrugPhenytoin

    Single dose of Phenytoin 125 mg/5 ml suspension made by Laboratorios Pfizer, S.A. de C.V.

  • DrugEpamin

    Single dose Epamin 125 mg/5 ml suspension made by McNeil LA LLC

06

What researchers measure

Primary outcomes

  1. Area under the curve (AUC): The AUC from administration to the last sampling time will be determined by the trapezoid method.

    Time frame: 0-168 h

  2. Maximum Concentration (Cmax): The maximum plasmatic concentration (Cmax) will be obtained as the highest concentration observed in the sampling interval.

    Time frame: 0-168 h

  3. Time maximum concentration (tmax) is observed. Will be reported as the time at which the maximum concentration is observed.

    Time frame: 0-168 h

Secondary outcomes

  1. Constant of elimination (ke): Will be determined as the slope from the linear logarithmic regression of the terminal phase of the logarithmic graph of concentration over time.

    Time frame: 0-168 h

07

Study locations

1 site
  • Pfizer Investigational Site
    Mexico, Distrito Federal 14050, Mexico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01122953
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
May 13, 2010
Start date
Apr 2010
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Jan 27, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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

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