Phase 1Completed
A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy Adults
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
- Sponsor
- Pfizer (Industry)
- Enrolment
- 35 enrolled
- Conditions
- Healthy
- Interventions
- Phenytoin (Ascoli); Phenytoin (Vega Baja)
- Ages
- adults, older adults
- Registry
- NCT06466473
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
- Maximum Observed Plasma Concentration (Cmax) of Phenytoin
History
Last registry update
Primary completion
Started
Registered