Recruiting
Phase 1

Divalproex Sodium

Sponsor:

Vince & Associates Clinical Research, Inc.

Code:

NCT01898676

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Divalproex Sodium Extended-release 250mg

DEPAKOTE 250mg

Study Details

Brief summary:

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

Conditions

Epilepsy

Study ID

NCT01898676

Start date

Jul, 2013

Status verified date

Jun, 2013

Completion date

Dec, 2013

Anticipated

Primary completion date

Aug, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Divalproex Sodium Extended Release 250mg

Treatment 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.

active comparator: DEPAKOTE 250mg

Treatment 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

Divalproex Sodium Extended-release 250mg

Two tablets of Divalproex Sodium Extended-Release 250mg will be given to the subject in two treatment periods

DEPAKOTE 250mg

Two tablets of DEPAKOTE 250mg will be given to the subject in two treatment periods.

Primary outcome measure

  • Evaluate generic divalproex sodium extended release to Depakote ER [ Time Frame: Approximately 2.5 months ]

Central Contacts and Locations

Locations

Vince & Associates Clinical Research, Inc.

Recruiting

Overland Park, Kansas, United States, 66212

Contacts

David Wood

913-696-1601dwood@vinceandassociates.com

Principal Investigator:

Bradley D Vince, DO

More Information

Sponsor

Vince & Associates Clinical Research, Inc.

Last update posted

Jul 12, 2013

Last verified

Jun, 2013

Keywords

  • Extended-release divalproex sodium
  • Depakote ER

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vince & Associates Clinical Research, Inc. on 2013-07-12.