Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg (NCT01184391) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg
United States17 participantsStarted 2007-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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,
✓. Within normal limits or non-clinically significant laboratory evaluation results for the following tests:
✓. Negative Hepatitis B and Hepatitis C tests,
✓. Negative HIV test,
Exclusion criteria
✕. 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).
✕. Donation or loss of a significant volume of blood or plasma (\> 450 mL) within 28 days prior to the initial dose of study medication.