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

Healthy Clinical Trial

Official title:
A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 2-WAY CROSSOVER, PIVOTAL BIOEQUIVALENCE STUDY COMPARING 50-MG CHEWABLE DILANTIN® INFATABS® MANUFACTURED AT VEGA BAJA (PUERTO RICO) AND ASCOLI (ITALY) IN HEALTHY ADULT PARTICIPANTS UNDER FASTING CONDITIONS

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06466473
Study type Interventional
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Status Not yet recruiting
Phase Phase 1
Start date July 16, 2024
Completion date November 8, 2024
View Details
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