- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01184391
Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg
August 17, 2010 updated by: Mylan Pharmaceuticals Inc
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
West Virginia
-
Morgantown, West Virginia, United States, 26505
- Kendle International Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test: Divalproex Sodium
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG
|
1 X 500 mg Tablet, under fasting conditions.
|
Active Comparator: Reference: Depakote Tablets
DEPAKOTE® Tablets, 500 MG Abbott Laboratories
|
1 x 500 mg tablet, under fasting conditions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: 30 days
|
Maximum plasma concentration (micrograms/mL)
|
30 days
|
AUCL
Time Frame: 30 days
|
Area under the concentration time curve from time zero to the last measurable concentration(micrograms x mL/hr)
|
30 days
|
AUCI
Time Frame: 30 days
|
Area under the concentration time curve from time zero to infinity (micrograms x mL/hr)
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
September 24, 2009
First Submitted That Met QC Criteria
August 17, 2010
First Posted (Estimate)
August 18, 2010
Study Record Updates
Last Update Posted (Estimate)
August 18, 2010
Last Update Submitted That Met QC Criteria
August 17, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIVA-0771
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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