Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Divalproex Sodium 125 MG Delayed Release Tablets Sandoz |
|
| 2 | Active Comparator | Depakote 125 MG DR Tablets Abbott Laboratories USA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divalproex Sodium | Drug |
| ||
| Depakote DR Tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence according to US FDA Guidelines | 9 Days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xueyu Chen, MD, Ph.D, FRCP(C) | Pharma Medica Research, Inc. | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |