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

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vince & Associates Clinical Research, Inc.
• Collaborator: Food and Drug Administration (FDA)
• Treatments: Valproic Acid

Criteria

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

• 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

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

• 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.

• Blood donation within 8 weeks of admission to this study