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OpenTrials
Completed

NCT Number: NCT01122940

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Mexico City, 14050, Mexico

About this study

Bioequivalence

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Epamin: Reference Drug

Drug

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

Phenytoin: Study Drug

Drug

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

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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Bioequivalence Study Of 10ml Dose Of Phenytoin 0.75g/100ml Suspension Made By Laboratorios Pfizer, S.A. De C.V. Versus Epamin® 0.75g/100ml Made By McNeil LA LLC, Study In 34 Healthy Volunteers Under Fasting Conditions.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 13, 2010
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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