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

Status unconfirmed · Phase 1

Conditions studied: Epilepsy

In brief

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

Key facts

Study ID

NCT01898676

Run by

Vince & Associates Clinical Research, Inc.

People needed

16

Starts

2013-07-01

Expected to finish

2013-12-01

Last updated by the study team

2013-07-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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.
• Blood donation within 8 weeks of admission to this study

Where it is running

• Vince & Associates Clinical Research, Inc. — Overland Park, Kansas, United States (enrolling)

Full record on ClinicalTrials.gov

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