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

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT01122940

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

31.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Epamin: Reference Drug Drug: Phenytoin: Study Drug	Phase 1

Detailed Description

Bioequivalence

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official 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.

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Epamin: McNeil LA LLC	Drug: Epamin: Reference Drug Single dose of 75 mg (10 ml in suspension) of Epamin
Experimental: Phenytoin: Laboratorios Pfizer SA DE CV	Drug: Phenytoin: Study Drug Single dose of 75 mg (10 ml in suspension) of Phenytoin

Arm

Intervention/Treatment

Active Comparator: Epamin: McNeil LA LLC

Drug: Epamin: Reference Drug

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

Experimental: Phenytoin: Laboratorios Pfizer SA DE CV

Drug: Phenytoin: Study Drug

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Mexico	Distrito Federal	Mexico	14050

Sponsors and Collaborators

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

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT01122940

Other Study ID Numbers:

A4121008

First Posted:

May 13, 2010

Last Update Posted:

Jan 27, 2021

Last Verified:

Jan 1, 2011

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

Bioequivalence

Phenytoin

Epamin

Additional relevant MeSH terms:

Phenytoin

Study Results

No Results Posted as of Jan 27, 2021