drugset
drugset / Trial / NCT00648076

Food Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg

NCT00648076 ↗

Phase 1 Completed 40 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-label

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 (1 x 500 mg) dose administered under fed conditions.

Timeline

Start
2004-12
Primary completion
2004-12
Completion
2004-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Divalproex Sodium Small molecule 500 mg Oral
Comparator Valproate Small molecule 500 mg Oral

Indications

No indication recorded.