HealthyPhase 1NCT00834990
Divalproex Sodium Delayed-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 will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets) in healthy subjects under non-fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy 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
- Sep 2003to Sep 2003
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Screening Demographics: All subjects selected for this study will be healthy men or women 18-65 years of age, inclusive, at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30.
- Screening Procedures: Each subject will complete the screening process within 28 days prior to period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
- The screening clinical laboratory procedures will include:
- HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count
- CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase
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- HIV antibody, hepatitis B surface antigen, hepatitis C antibody screens
- URINALYSIS: by dipstick; full microscopic examination if dipstick positive
- URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine
- SERUM PREGNANCY SCREEN (female subjects only)
- FOLLICLE STIMULATING HORMONE (FSH; female subjects only): verify postmenopausal status
- If female and:
- Is postmenopausal for at least 1 year with postmenopausal status defined as: > 60 years of age and amenorrheic for at least one year; if 60 years of age or younger, must also have a serum FSH level > 30 IU/L; or
- Is surgically sterile for at least 6 months (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
Who cannot join
- Subjects with a recent history of drug or alcohol addiction or abuse.
- Subjects with the presence 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 investigators).
- Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- Subjects demonstrating a positive hepatitis B surface antigen screen, a positive hepatitis C antibody screen, or a reactive HIV antibody screen.
- Subjects demonstrating a positive drug abuse screen when screened for this study.
- Female subjects demonstrating a positive pregnancy screen.
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- Female subjects who are currently breastfeeding.
- Subjects with a history of allergic response(s) to divalproex sodium or related drugs.
- Subjects with a history of clinically significant allergies including drug allergies.
- Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- Subjects who currently or report using tobacco products within 90 days of Period I dose administration.
- Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
- Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
- Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.
- Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
- Subjects who report an intolerance of direct venipuncture.
- Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Relative Bioavailability Study of 500 mg Divalproex Sodium Delayed-Release Tablets Under Non-Fasting Conditions
This study will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets) in healthy subjects under non-fasting conditions.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- divalproex sodium, Depakote®
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
divalproex sodiumDrug
delayed-release 500 mg tablet
Depakote®Drug
delayed-release 500 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: divalproex sodium |
| 2 | Active comparator | Not described Receives: Drug: Depakote® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum Observed Concentration)
Bioequivalence based on Cmax.
Measured: Blood samples collected over a 72 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on AUC0-t.
Measured: Blood samples collected over a 72 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on AUC0-inf.
Measured: Blood samples collected over a 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 posted3 Feb 2009 (estimated)
- Study startSep 2003
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834990
- Sponsor's protocol ID
- R03-593
- Status last verified
- Aug 2009
- First submitted
- 30 Jan 2009
- Last updated
- 20 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 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 Delayed-Release Tablets Under Non-Fasting Conditions
- ClinicalTrials.gov ID
- NCT00834990
- Acronym / sponsor ID
- R03-593
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 4 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets) in healthy subjects under non-fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: divalproex sodium |
| 2 | Active comparator | Drug: Depakote® |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Screening Demographics: All subjects selected for this study will be healthy men or women 18-65 years of age, inclusive, at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30.
- Screening Procedures: Each subject will complete the screening process within 28 days prior to period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
- HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count
- CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase
Key exclusion criteria (18 listed)
- Subjects with a recent history of drug or alcohol addiction or abuse.
- Subjects with the presence 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 investigators).
- Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- Subjects demonstrating a positive hepatitis B surface antigen screen, a positive hepatitis C antibody screen, or a reactive HIV antibody screen.
- Subjects demonstrating a positive drug abuse screen when screened for this study.
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 sodiumdelayed-release 500 mg tablet | Drug | 1 |
| Depakote®delayed-release 500 mg tablet | Drug | 2 |
Primary outcome
Cmax (Maximum Observed Concentration)
Time frame: Blood samples collected over a 72 hour period.
Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 72 hour period.
Bioequivalence based on AUC0-t.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 72 hour period.
Bioequivalence based on AUC0-inf.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
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 14 inclusion and 18 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 20 Aug 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?
Yes. Results are posted in the registry (first posted 4 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 a 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 20 Aug 2009; AzTrials last refreshed its copy on 27 Oct 2026.