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UNKNOWNPHASE1

A Study in Stable Epilepsy Patients Comparing Brand and Generic Divalproex Sodium Extended Release Tablets

An Open Label, Randomized, Four-period, Two-sequence, Fully Replicated, Single-dose, Crossover Study of the Relative Bioavailability of Two Formulations of Extended-release Divalproex Sodium Tablets in Fed Patients With Stable Epilepsy.

NCT01898676•Vince & Associates Clinical Research, Inc.

View on ClinicalTrials.gov

Summary

A study in stable epilepsy patients comparing levels of valproic acid after administration of brand and generic divalproex sodium extended release tablets.

Detailed Description

Study consists of a screening visit, four treatment periods and a final follow-up visit. Each treatment period consists of a four night in-house stay followed by two outpatient visits. Each treatment period will be separated by a washout period. During each treatment period, safety evaluations will include vital signs, physical exams, safety laboratory tests, weight measurement, electrocardiograms, adverse event collection and concomitant medication recording. Pharmacokinetic blood samples will be collected during each treatment period. Seizure activity will be recorded in a seizure diary during the study. A standardized high-fat, high-calorie meal will be served prior to each dose during each treatment period.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Able to understand, sign and date the informed consent form
•Male or female 18 to 55 years old with a diagnosis of epilepsy who are stable
•Body mass 18 to 34 kg/m, inclusive
•Is continuously receiving a fixed dose of their AED medication(s)for a minimum of 30 days prior to screening
•Stay on the same dosages of their routine concomitant medications throughout the study
•Healthy, as determined by pre-study medical history, vital signs, physical exam, ECG and the opinion of the investigator
•Normal renal function per laboratory test
•No clinically relevant labs.
•Negative for hepatitis B, C and HIV
•For females, negative pregnancy test
+4 more criteria

Exclusion Criteria

•History or presence of clinically significant medical disorders
•Have a current psychiatric disorder
•History of status epilepticus within 90 days of screening
•Any other condition that the investigator would feel could interfere with the safety of the subject or the study protocol.
•Taking three or more AED medications
•Use of felbamate, aspirin, carbapenem antibiotics, rifampin, ritonavir, macrolide antibiotics, cholestyramine, and/or risperidone.
•Use of any investigational agent or medical device within 30 days of screening.
•History of clinically significant drug allergy that in the opinion of the investigator may compromise the subject's safety or study results.
•History of known hypersensitivity to divalproex sodium or its excipients
•History of alcohol or drug abuse or dependence in the past 5 years
+6 more criteria

Locations (1)

Vince & Associates Clinical Research, Inc.

Overland Park, Kansas, United States

Key Dates

Start Date

July 1, 2013

Primary Completion Date

August 1, 2013

Completion Date

December 1, 2013

Last Updated

July 12, 2013

Enrollment

ESTIMATED participants

Conditions

Epilepsy

Interventions

Divalproex Sodium Extended-release 250mg

DRUG

DEPAKOTE 250mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study in Stable Epilepsy Patients Comparing Brand and Generic Divalproex Sodium Extended Release Tablets

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

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