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This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate IR followed by Topiramate ER | Other | Dosing with IR followed by dosing with ER |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate IR | Drug |
|
| |
| Topiramate ER |
| Measure | Description | Time Frame |
|---|---|---|
| relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Baroldi, MD, PhD | Supernus Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyle Patrick | Phoenix | Arizona | 85013 | United States | ||
| Victor Biton |
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It was a open-label study
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| Drug |
|
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Mohammed Bari | National City | California | 91950 | United States |
| Dr. Segal | Fort Lauderdale | Florida | 33308 | United States |
| Dr. Sackellares | Gainesville | Florida | 32607 | United States |
| James Kiely | Atlanta | Georgia | 30342 | United States |
| Bassem El-Nabbout | Wichita | Kansas | 67214 | United States |
| Dr. Chumley | Lexington | Kentucky | 20513 | United States |
| Dr. Fisher | Oklahoma City | Oklahoma | 73112 | United States |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 | Ketoses |
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