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

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Phenytoin: Study Drug; Drug: Epamin: Reference Drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT01122940

A4121008

Details and patient eligibility

About

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.

Full description

Bioequivalence

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Epamin: McNeil LA LLC

Active Comparator group

Treatment:

Drug: Epamin: Reference Drug

Phenytoin: Laboratorios Pfizer SA DE CV

Experimental group

Treatment:

Drug: Phenytoin: Study Drug