EpilepsyPhase 1NCT00913848
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions
A Phase 1 study testing Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) and Depakote 500 mg DR Tablets (Abbott Laboratories, USA) in people with Epilepsy and Bipolar Disorder, run by Sandoz.
Trial summary
To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fed conditions. Read more about this study
- Who is it for?
- Ages 21 to 47 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Bipolar Disorder
- What is being tested?
- Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) and Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Oct 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 47 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Who cannot join
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
About this study
Official title: A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions
To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fed conditions.
- Conditions
- Epilepsy, Bipolar Disorder
- Being tested
- Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA), Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
- Keywords
- Treatment of Epilepsy and Bipolar Disorder
- Medical subject headings
- Epilepsy, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)Drug
Depakote 500 mg DR Tablets (Abbott Laboratories, USA)Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) Receives: Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) |
| 2 | Active comparator | Depakote 500 mg DR Tablets (Abbott Laboratories, USA) Receives: Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on AUC and Cmax
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startOct 2005
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Xueyu (Eric) Chen, M.D., Principal investigator, Pharma Medica Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913848
- Sponsor's protocol ID
- 2005-1050
- Status last verified
- Jun 2009
- First submitted
- 2 Jun 2009
- Last updated
- 28 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions
- ClinicalTrials.gov ID
- NCT00913848
- Acronym / sponsor ID
- 2005-1050
- Conditions
- Epilepsy, Bipolar Disorder
- Keywords
- Treatment of Epilepsy and Bipolar Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) |
| 2 | Active comparator | Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)Depakote 500 mg DR Tablets (Abbott Laboratories, USA) |
Who may qualify
- Ages
- 21 to 47 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Key exclusion criteria (2 listed)
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) | Drug | 1 |
| Depakote 500 mg DR Tablets (Abbott Laboratories, USA) | Drug | 2 |
Primary outcome
Bioequivalence based on AUC and Cmax
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xueyu (Eric) Chen, M.D. principal investigator
Pharma Medica Research, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) and Depakote 500 mg DR Tablets (Abbott Laboratories, USA) in people with Epilepsy and Bipolar Disorder, run by Sandoz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence based on AUC and Cmax (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.