A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy Adults

NCT06466473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-10-08

No results posted yet for this study

Summary

The purpose of this study is to understand how the different formulation of phenytoin is taken up into the blood in Healthy Adults.

This study is seeking healthy adult participants. All the study participants will receive Phenytoin 50 mg chewable tablets manufactured at Ascoli and Vega Baja manufacturing site.

We will measure how the phenytoin will be taken up into the blood in Healthy Adults following oral dosing of Phenytoin.

This will help us determine if the Phenytoin 50 mg chewable tablets manufactured at Ascoli and Vega Baja manufacturing site are similar or not.

Conditions

  • Healthy

Interventions

DRUG

Phenytoin (Ascoli)

Phenytoin 50mg chewable tablets

DRUG

Phenytoin (Vega Baja)

Phenytoin 50mg chewable tablets

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2024-10-04
Completion
2024-10-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06466473 on ClinicalTrials.gov