A Study in Stable Epilepsy Patients Comparing Brand and Generic Divalproex Sodium Extended Release Tablets
Epilepsy
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.
1 other identifier
interventional
16
1 country
1
Brief Summary
A study in stable epilepsy patients comparing levels of valproic acid after administration of brand and generic divalproex sodium extended release tablets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2013
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 12, 2013
June 1, 2013
1 month
June 17, 2013
July 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate generic divalproex sodium extended release to Depakote ER
This is an open-label, randomized, two-sequence, two-treatment, single dose, four-period, fully replicated crossover study in which 16 subjects will receive one of the two study drugs, Depakote ER or a generic equivalent, during each treatment period. Subjects will be patients with epilepsy who are otherwise healthy and who are stable on anti-epileptic therapy, not including any formulation of divalproex sodium.
Approximately 2.5 months
Study Arms (2)
Divalproex Sodium Extended Release 250mg
ACTIVE COMPARATORTreatment A: A single 2-tablet dose of divalproex sodium extended-release tablet, 250mg. Each subject will have 2 treatments with this medication and two treatments with a single 2-tablet dose of DEPAKOTE 250mg tablet.
DEPAKOTE 250mg
ACTIVE COMPARATORTreatment B: A single 2-tablet dose of DEPAKOTE ER tablet, 250mg. Each subject will have 2 treament period with this medication and 2 treatment periods with a single 2-tablet dose of Divalproex Sodium Extended-Release 250mg tablet.
Interventions
Two tablets of Divalproex Sodium Extended-Release 250mg will be given to the subject in two treatment periods
Two tablets of DEPAKOTE 250mg will be given to the subject in two treatment periods.
Eligibility Criteria
You may qualify if:
- 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
- Negative for drugs of abuse and alcohol
- Nonsmoker or has not smoked within the past six months.
- Some over-the-counter medications may be permitted at the discretion of the investigator
- Able to communicate well and comply with study procedures, requirements and restrictions
You may not qualify if:
- 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
- Consumed alcohol, caffeine or other xanthine-containing foods or beverages within 48 hours prior to each clinic admission.
- Consumed grapefruit and/or grapefruit containing products within days prior to admission to the clinic on Day -1 and they agree not to consume grapefruit and/or grapefruit containing products for the duration of their study involvement
- Participated in any strenuous physical exercise within 72 hours before admission to the clinic on Day 1 and agrees to abstain from the duration of their study involvement.
- Acute illness at screening and/or at admission to the clinic
- Lactose intolerance or unusual dietary habits.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley D. Vince, DO
Vince & Associates Clinical Research, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2013
First Posted
July 12, 2013
Study Start
July 1, 2013
Primary Completion
August 1, 2013
Study Completion
December 1, 2013
Last Updated
July 12, 2013
Record last verified: 2013-06