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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-03

Study Completion Date

2024-10-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions

NCT00974441

Healthy

COMPLETED PHASE1

A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers

NCT01629368

Healthy Volunteer

COMPLETED PHASE1

A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers

NCT01365403

Healthy Volunteer

COMPLETED PHASE1

Fasting Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg

NCT00647712

Healthy

COMPLETED PHASE1

A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults

NCT07066722

HIV Infections

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phenytoin manufactured at Vega Baja site

Group Type ACTIVE_COMPARATOR

Phenytoin (Vega Baja)

Intervention Type DRUG

Phenytoin 50mg chewable tablets

Phenytoin manufactored at Ascoli site

Group Type EXPERIMENTAL

Phenytoin (Ascoli)

Intervention Type DRUG

Phenytoin 50mg chewable tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Phenytoin (Ascoli)

Phenytoin 50mg chewable tablets

Intervention Type DRUG

Phenytoin (Vega Baja)

Phenytoin 50mg chewable tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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.
2. Body mass index (BMI) of 16-32 kg/m2; and a total body weight \>45 kg (100 lb).

Exclusion Criteria

1. 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).
2. 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.
3. History of hypersensitivity to phenytoin or its inactive ingredients.
4. 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.
5. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior to the first dose of study intervention.
6. Current use of any prohibited concomitant medication(s).
7. History of febrile illness within 5 days prior to first dose.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes