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

NCT06466473 | Completed Phase 1 FDA Drug

• 1 other identifier: A4121018
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Phenytoin; Healthy participants; Pharmacokinetic; Epilepsy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs) According to Seriousness

  Baseline, up to 35 days post last dose.

Study Arms (2)

Phenytoin manufactured at Vega Baja site

ACTIVE COMPARATOR

Drug: Phenytoin (Vega Baja)

Phenytoin manufactored at Ascoli site

EXPERIMENTAL

Drug: Phenytoin (Ascoli)

Interventions

Phenytoin (Ascoli) DRUG

Phenytoin 50mg chewable tablets

Phenytoin manufactored at Ascoli site

Phenytoin (Vega Baja) DRUG

Phenytoin 50mg chewable tablets

Phenytoin manufactured at Vega Baja site

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male participants and female participants of non-childbearing potential aged 18 years or older determined by medical evaluation including detailed medical history, complete physical examination, blood pressure (BP) and pulse rate measurement, 12-lead electrocardiogram (ECG), and/or clinical laboratory tests.
• Body mass index (BMI) of 16-32 kg/m2; and a total body weight \>45 kg (100 lb).

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Female participants of childbearing potential; pregnant female participants; breastfeeding female participants; male participants with partners currently pregnant; male participants able to father children who, with their partner(s) are at risk for pregnancy and are unwilling or unable to use a highly effective method of contraception.
• History of hypersensitivity to phenytoin or its inactive ingredients.
• Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior to the first dose of study intervention.
• Current use of any prohibited concomitant medication(s).
• History of febrile illness within 5 days prior to first dose.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Epilepsy

Interventions

Phenytoin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 20, 2024
• Study Start: July 3, 2024
• Primary Completion: October 4, 2024
• Study Completion: October 4, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)