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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenytoin manufactured at Vega Baja site | Active Comparator |
| |
| Phenytoin manufactored at Ascoli site | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenytoin (Ascoli) | Drug | Phenytoin 50mg chewable tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) | 72 hours | |
| Maximum Observed Plasma Concentration (Cmax) of Phenytoin | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) According to Seriousness | Baseline, up to 35 days post last dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - New Haven | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010672 | Phenytoin |
| ID | Term |
|---|---|
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 |
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| Phenytoin (Vega Baja) |
| Drug |
Phenytoin 50mg chewable tablets |
|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |