Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466473
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2024-06-14
Brief Title:
A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy Adults
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None