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Completed

NCT Number: NCT06466473

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Phenytoin (Ascoli)

Drug

Phenytoin 50mg chewable tablets

Phenytoin (Vega Baja)

Drug

Phenytoin 50mg chewable tablets

Primary outcomes

  1. Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)

    Time frame: 72 hours

  2. Maximum Observed Plasma Concentration (Cmax) of Phenytoin

    Time frame: 72 hours

Secondary outcomes

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

    Time frame: Baseline, up to 35 days post last dose.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 20, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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