SeizuresPhase 1NCT00864006
Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions
A Phase 1 study testing Divalproex Sodium and Depakote DR Tablets in people with Seizures, run by Sandoz.
Trial summary
The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Seizures
- What is being tested?
- Divalproex Sodium and Depakote DR Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Oct 2006
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No clinically significant findings on physical examination, medical history or laboratory tests on screening
Who cannot join
- Positive test for HIV or Hepatitis B and C
- History of sensitivity to valproic acid or related compounds
About this study
Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions
The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets.
- Conditions
- Seizures
- Being tested
- Divalproex Sodium, Depakote DR Tablets
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex SodiumDrug
Depakote DR TabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Divalproex Sodium 125 MG Delayed Release Tablets Sandoz Receives: Drug: Divalproex Sodium |
| 2 | Active comparator | Depakote 125 MG DR Tablets Abbott Laboratories USA Receives: Drug: Depakote DR Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence according to US FDA Guidelines
Measured: 9 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startOct 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Xueyu Chen, MD, Ph.D, FRCP(C), Principal investigator, Pharma Medica Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864006
- Sponsor's protocol ID
- 2006-1294
- Status last verified
- Mar 2009
- First submitted
- 17 Mar 2009
- Last updated
- 29 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 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 125 MG Delayed Release Tablets Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00864006
- Acronym / sponsor ID
- 2006-1294
- Conditions
- Seizures
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 18 Mar 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.
The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets.
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 SodiumDivalproex Sodium 125 MG Delayed Release Tablets Sandoz |
| 2 | Active comparator | Drug: Depakote DR TabletsDepakote 125 MG DR Tablets Abbott Laboratories USA |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No clinically significant findings on physical examination, medical history or laboratory tests on screening
Key exclusion criteria (2 listed)
- Positive test for HIV or Hepatitis B and C
- History of sensitivity to valproic acid or related compounds
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 | Drug | 1 |
| Depakote DR Tablets | Drug | 2 |
Primary outcome
Bioequivalence according to US FDA Guidelines
Time frame: 9 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 29 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 Chen, MD, Ph.D, FRCP(C) principal investigator
Pharma Medica Research, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Divalproex Sodium and Depakote DR Tablets in people with Seizures, 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 29 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 according to US FDA Guidelines (time frame: 9 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 29 Mar 2017.