Status:
COMPLETED
Food Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg
Lead Sponsor:
Mylan Pharmaceuticals Inc
Conditions:
Healthy
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a single, oral 500 mg (...
Eligibility Criteria
Inclusion
- Age: 18 years and older.
- Sex: Male.
- Weight: At least 60 kg (132 lbs) and within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, including vital signs, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
- During the course of the study, from study screen until study exit, all males must use a spermicide-containing barrier method of contraception in addition to their current contraceptive device (if any). This requirement should be documented in the informed consent form.
Exclusion
- Institutionalized subjects will not be used.
- Social Habits:
- Use of any tobacco products within 1 year of the start of the study.
- Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within 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.
- A positive test for any drug included in the urine drug screen.
- History of drug and/or alcohol abuse.
- Medications:
- Use of any prescription or over-the-counter (OTC) medications within 14 days prior to the initial dose of study medication.
- Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- Diseases:
- History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
- Acute illness at the time of either the pre-study medical evaluation or dosing.
- A positive HIV, hepatitis B, or hepatitis C test.
- Abnormal and clinically significant laboratory test results:
- Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- Abnormal and clinically relevant ECG tracing.
- 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 valproic acid or any other 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00648076
Start Date
December 1 2004
End Date
December 1 2004
Last Update
September 25 2009
Active Locations (1)
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1
Cedra Clinical Research, LLC.
Austin, Texas, United States, 78759