HealthyPhase 1NCT01184391
Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg
A Phase 1 study testing DEPAKOTE® Tablets, 500 MG and DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.
Trial summary
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administration under 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?
- DEPAKOTE® Tablets, 500 MG and DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Aug 2007
- 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
- Age: 18 years and older.
- Sex: Females not of child bearing potential and males.
- No hormonal contraceptives or hormonal replacement therapies are permitted in this study.
- Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- postmenopausal with spontaneous amenorrhea for at least one (1) year, or spontaneous amenorrhea for less than one (1) year with serum FSH levels > 40 mIU/ml, or
- bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
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- total hysterectomy and an absence of bleeding for at least 3 months.
- During the course of the study, from study screen until study exit - including the washout period, all men must use a spermicide containing barrier method of contraception in addition to their current contraceptive method. These instructions should be documented in the informed consent form.
- Weight Restrictions:
- At least 60 kg (132 lbs) for men and
- At least 48 kg (106 lbs) for women
- All subjects will have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 19 (see Part II, Administrative Aspects of Bioequivalence Protocols). BMI values should be rounded to the nearest integer (ex. 30.4 rounds down to 30, while 18.5 rounds up to 19)
- All subjects should be judged by the principal or sub-investigator physician listed on the Form FDA 1572 as normal and healthy during a pre-study medical evaluation performed within 21 days of the initial dose of study medication which will include:
- Normal or non-clinically significant physical examination including vital signs,
- Within normal limits or non-clinically significant laboratory evaluation results for the following tests:
- Serum Chemistries: sodium, potassium, chloride, BUN, iron, albumin, total protein AST, Alk. Phos., Calcium, Creatinine, ALT, Total bilirubin, Total Cholesterol, Phosphate, Uric Acid, Non-fasting Glucose Triglycerides
- Hematology: Platelet Count, Hemoglobin, Leukocyte Differential, Hematocrit, Red Blood Cells
- Urinalysis: Appearance, Specific Gravity, Protein pH, Microscopic Examination
- Negative Hepatitis B and Hepatitis C tests,
- Negative HIV test,
- Normal or non-clinically significant 12-lead ECG
- Negative urine drug screen for all of the following compounds: amphetamines, barbiturates, benzodiazepines, cannabinoid, cocaine, methadone, opiates, and phencyclidine
Who cannot join
- Institutionalized subjects will not be used.
- Social Habits:
- Use of any tobacco-containing products within 1 year of the start of the study.
- Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- Any recent, significant change in dietary or exercise habits.
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- Individual has a history of drug and/or alcohol abuse.
- Medications:
- Use of any prescription or over-the-counter (OTC) medications within fourteen (14) days prior to the initial dose of study medication.
- Use of any hormone replacement therapy within 3 months prior to study medication dosing.
- Use of any medication known to induce or inhibit hepatic enzyme activity within 28 days prior to the initial dose of study medication (see Part II, Administrative Aspects of Bioequivalence Protocols for list).
- Diseases:
- History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, congenital metabolic disorders or neurologic disease.
- Acute illness at the time of either the pre-study medical evaluation or dosing.
- All laboratory values reflecting hepatic function must be with in 10% of the upper range of normal in order to be considered not clinically significant.
- Subjects who have known urea cycle disorders which are a group of uncommon genetic abnormalities (e.g. ornithine transcarbamylase deficiency).
- Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
- Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- Allergy or hypersensitivity to Divalproex Sodium or any related products.
- History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
- Consumption of grapefruit or grapefruit containing products within 7 days of drug administration
Trial locations and contacts
1 site in 1 country.
United States1 site
Kendle International Inc.
Morgantown, West Virginia, 26505
About this study
Official title: Single-Dose Fasting Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets (500 mg; Mylan) and Depakote Tablets (500 mg; Abbott) in Healthy Adult Male And Female (Not of Childbearing Potential) Volunteers
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.
- Conditions
- Healthy
- Being tested
- DEPAKOTE® Tablets, 500 MG, DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEPAKOTE® Tablets, 500 MGDrug
1 x 500 mg tablet, under fasting conditions
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MGDrug
1 X 500 mg Tablet, under fasting conditions.
| Study group | Role | What they receive |
|---|---|---|
| Test: Divalproex Sodium | Experimental | DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG Receives: Drug: DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG |
| Reference: Depakote Tablets | Active comparator | DEPAKOTE® Tablets, 500 MG Abbott Laboratories Receives: Drug: DEPAKOTE® Tablets, 500 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration (micrograms/mL)
Measured: 30 days
AUCL
Area under the concentration time curve from time zero to the last measurable concentration(micrograms x mL/hr)
Measured: 30 days
AUCI
Area under the concentration time curve from time zero to infinity (micrograms x mL/hr)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startJul 2007
- Primary completionAug 2007
- Study completionAug 2007
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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184391
- Sponsor's protocol ID
- DIVA-0771
- Status last verified
- Aug 2010
- First submitted
- 24 Sep 2009
- Last updated
- 18 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Fasting Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets (500 mg; Mylan) and Depakote Tablets (500 mg; Abbott) in Healthy Adult Male And Female (Not of Childbearing Potential) Volunteers
- ClinicalTrials.gov ID
- NCT01184391
- Acronym / sponsor ID
- DIVA-0771
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 18 Aug 2010 (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 objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test: Divalproex Sodium | Experimental | Drug: DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MGDIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG |
| Reference: Depakote Tablets | Active comparator | Drug: DEPAKOTE® Tablets, 500 MGDEPAKOTE® Tablets, 500 MG Abbott Laboratories |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age: 18 years and older.
- Sex: Females not of child bearing potential and males.
- Weight Restrictions:
- All subjects should be judged by the principal or sub-investigator physician listed on the Form FDA 1572 as normal and healthy during a pre-study medical evaluation performed within 21 days of the initial dose of study medication which will include:
- Normal or non-clinically significant physical examination including vital signs,
Key exclusion criteria (21 listed)
- Institutionalized subjects will not be used.
- Social Habits:
- Medications:
- Diseases:
- Subjects who have known urea cycle disorders which are a group of uncommon genetic abnormalities (e.g. ornithine transcarbamylase deficiency).
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 |
|---|---|---|
| DEPAKOTE® Tablets, 500 MG1 x 500 mg tablet, under fasting conditions | Drug | Reference: Depakote Tablets |
| DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG1 X 500 mg Tablet, under fasting conditions. | Drug | Test: Divalproex Sodium |
Primary outcome
Cmax
Time frame: 30 days
Maximum plasma concentration (micrograms/mL)
AUCL
Time frame: 30 days
Area under the concentration time curve from time zero to the last measurable concentration(micrograms x mL/hr)
AUCI
Time frame: 30 days
Area under the concentration time curve from time zero to infinity (micrograms x mL/hr)
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 18 Aug 2010.
- Mylan Pharmaceuticals Inc - Clinical Trial ResultsLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 DEPAKOTE® Tablets, 500 MG and DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG in people with Healthy, run by Mylan Pharmaceuticals Inc 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 22 inclusion and 21 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 18 Aug 2010. 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 (time frame: 30 days). 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 18 Aug 2010.