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 objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose administered under fasting conditions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Topiramate Sprinkle Capsules 25 mg |
|
| 2 | Active Comparator | Topamax® Sprinkle Capsule 25 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate Sprinkle Capsules 25 mg | Drug | 25mg, single dose fasting |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. | blood collections through 144 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dorian Williams, M.D. | Kendle International Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kendle International Inc. | Morgantown | West Virginia | 26505 | United States |
Not provided
| Label | URL |
|---|---|
| Mylan Pharmaceuticals Inc. - Clinical Trial Results | View source |
| Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use | View source |
| Recalls, Market Withdrawals and Safety Alerts |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Topamax® Sprinkle Capsule 25 mg |
| Drug |
25mg, single dose fasting |
|
| View source |