HealthyPhase 1NCT00974012
Divalproex Sodium 500 mg Extended Release Tablets Under Non-Fasting Conditions
A Phase 1 study testing Divalproex Sodium and Depakote® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
This study was designed to compare the relative bioavailability (rate and extent of absorption) of Divalproex Sodium ER Tablets 500 mg with that of Depakote® ER Tablets 500 mg following a single, oral dose (1 x 500 mg extended release tablet) administered to healthy, adult subjects under non-fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Divalproex Sodium and Depakote®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who have completed the screening process within 28 days prior to Period 1 dosing
- Subjects who are healthy adult men and women 18 years of age or older at the time of dosing.
- Subjects who have a body mass index (BMI) between 19-30 kg/m2, inclusive, and weigh at least 110 lbs.
- Subjects who are healthy as documented by the medical history, physical examination (including bur may not be limited to and evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the normal range that might be considered clinically relevant by the study physician and investigator will be evaluated for individual cases, documented in study files and agreed upon by both the study physician and investigator prior to enrolling the subject in this study and for continued enrollment.
- Female subjects of postmenopausal (no menses) status for at least 1 year and has a serum FSH level greater than or equal to 30 mIU/mL or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
Who cannot join
- Subjects who report receiving any investigational drug within 30 days prior to Period 1 dosing.
- Subjects who report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
- Subjects whose clinical laboratory test values outside the accepted reference range and when confirmed on re-examination is deemed to be clinically significant.
- Subjects who demonstrate a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Subjects who report a history or allergic response(s) to divalproex or related drugs.
- Subjects who report the use of any systemic prescription medication in the 14 days prior to Period 1 dosing.
Show all 11Show fewer
- Subjects who report the use of any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period 1 dosing.
- Subjects who report a history of clinically significant allergies including drug allergies.
- Subjects who report a clinically significant illness during the 4 weeks prior to Period 1 dosing (as determined by the clinical investigators).
- Subjects who report a history of drug or alcohol addiction or abuse within the past year.
- Subjects who demonstrate a positive drug abuse screen for this study prior to Period 1 administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
PRACS Institute, Ltd.
East Grand Forks, Minnesota, 56721
About this study
Official title: A Relative Bioavailability Study of 500 mg Divalproex Sodium Extended Release Tablets Under Non-Fasting Conditions
This study was designed to compare the relative bioavailability (rate and extent of absorption) of Divalproex Sodium ER Tablets 500 mg with that of Depakote® ER Tablets 500 mg following a single, oral dose (1 x 500 mg extended release tablet) administered to healthy, adult subjects under non-fasting conditions.
- Conditions
- Healthy
- Being tested
- Divalproex Sodium, Depakote®
- Keywords
- Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex SodiumDrug
500 mg ER Tablet
Depakote®Drug
500 mg ER Tablet
| Study group | Role | What they receive |
|---|---|---|
| Divalproex Sodium | Experimental | 500 mg Extended Release Tablet Receives: Drug: Divalproex Sodium |
| Depakote® | Active comparator | 500 mg Extended Release Tablet Receives: Drug: Depakote® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Concentration
Measured: Blood samples collected over 72 hour period
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: Blood samples collected over 72 hour period
AUC0-t - Area under the concentration-time curve from time zero to time of last quantifiable concentration (per participant)
Measured: Blood samples collected over 72 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 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 HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James D Carlson, Pharm. D., Principal investigator, PRACS Institute, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974012
- Sponsor's protocol ID
- R06-0442
- Status last verified
- Sep 2009
- First submitted
- 9 Sep 2009
- Last updated
- 10 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of 500 mg Divalproex Sodium Extended Release Tablets Under Non-Fasting Conditions
- ClinicalTrials.gov ID
- NCT00974012
- Acronym / sponsor ID
- R06-0442
- Conditions
- Healthy
- Keywords
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 10 Sep 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.
This study was designed to compare the relative bioavailability (rate and extent of absorption) of Divalproex Sodium ER Tablets 500 mg with that of Depakote® ER Tablets 500 mg following a single, oral dose (1 x 500 mg extended release tablet) administered to healthy, adult subjects under non-fasting conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Divalproex Sodium | Experimental | Drug: Divalproex Sodium500 mg Extended Release Tablet |
| Depakote® | Active comparator | Drug: Depakote®500 mg Extended Release Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who have completed the screening process within 28 days prior to Period 1 dosing
- Subjects who are healthy adult men and women 18 years of age or older at the time of dosing.
- Subjects who have a body mass index (BMI) between 19-30 kg/m2, inclusive, and weigh at least 110 lbs.
- Subjects who are healthy as documented by the medical history, physical examination (including bur may not be limited to and evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the normal range that might be considered clinically relevant by the study physician and investigator will be evaluated for individual cases, documented in study files and agreed upon by both the study physician and investigator prior to enrolling the subject in this study and for continued enrollment.
- Female subjects of postmenopausal (no menses) status for at least 1 year and has a serum FSH level greater than or equal to 30 mIU/mL or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
Key exclusion criteria (11 listed)
- Subjects who report receiving any investigational drug within 30 days prior to Period 1 dosing.
- Subjects who report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
- Subjects whose clinical laboratory test values outside the accepted reference range and when confirmed on re-examination is deemed to be clinically significant.
- Subjects who demonstrate a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Subjects who report a history or allergic response(s) to divalproex or related drugs.
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 Sodium500 mg ER Tablet | Drug | Divalproex Sodium |
| Depakote®500 mg ER Tablet | Drug | Depakote® |
Primary outcome
Cmax - Maximum Observed Concentration
Time frame: Blood samples collected over 72 hour period
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Time frame: Blood samples collected over 72 hour period
AUC0-t - Area under the concentration-time curve from time zero to time of last quantifiable concentration (per participant)
Time frame: Blood samples collected over 72 hour period
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 10 Sep 2009.
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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.
James D Carlson, Pharm. D. principal investigator
PRACS Institute, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Divalproex Sodium and Depakote® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
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 5 inclusion and 11 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 10 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cmax - Maximum Observed Concentration (time frame: Blood samples collected over 72 hour period). The study lists 3 primary outcomes in all. 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 10 Sep 2009.