NCT06466473CompletedPhase 1
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Phenytoin manufactored at Ascoli site
Experimental
Intervention: Phenytoin (Ascoli) (Drug)
Phenytoin manufactured at Vega Baja site
Active Comparator
Intervention: Phenytoin (Vega Baja) (Drug)
Outcomes
Primary Outcomes
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Time Frame: 72 hours
Maximum Observed Plasma Concentration (Cmax) of Phenytoin
Time Frame: 72 hours
Secondary Outcomes
- Number of Participants With Adverse Events (AEs) According to Seriousness(Baseline, up to 35 days post last dose.)
Investigators
Study Sites (1)
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