drugset / Trial / NCT00834639
Divalproex Sodium Delayed-Release Tablets Under Fasting Conditions
RandomizedCrossoverOpen-label
Summary
This study will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets)in healthy subjects under fasting conditions.
Timeline
- Start
- 2003-09
- Primary completion
- 2003-09
- Completion
- 2003-09
Outcome
Met primary endpoint
registry Ratio of the T/R geometric mean x 100 97.36 (90% CI 93.68 to 101.18) NCT00834639 ↗
registry Ratio of the T/R geometric mean x 100 100.59 (90% CI 97.07 to 104.24) NCT00834639 ↗
registry Ratio of the T/R geometric mean x 100 100.36 (90% CI 97.35 to 103.46) NCT00834639 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Divalproex Sodium | Small molecule | 500 mg | Oral |
Indications
No indication recorded.