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CompletedNCT01122940Updated Jan 27, 2021

Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.

A Phase 1 interventional study of Epamin: Reference Drug and Phenytoin: Study Drug 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
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

Bioequivalence

02

Conditions studied

  • Healthy

Keywords

  • Bioequivalence
  • Phenytoin
  • Epamin
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, 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.

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
32 participants (actual)

Study arms

  • Active comparator
    Epamin: McNeil LA LLC

    Drug: Epamin: Reference Drug

  • Experimental
    Phenytoin: Laboratorios Pfizer SA DE CV

    Drug: Phenytoin: Study Drug

Interventions

  • DrugEpamin: Reference Drug

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

  • DrugPhenytoin: Study Drug

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

06

What researchers measure

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)

    Time frame: April 2010 - May 2010

07

Study locations

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

References and documents

09

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 ↗
10

Registry details

Key details

Study ID
NCT01122940
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
May 13, 2010
Start date
Jul 2010
Primary completion
Aug 2010
Completion
Aug 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 Jan 2011. 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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