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The purpose of the study is to prove the bioequivalence of brand and generic topiramate.
Generic antiepileptic drugs (AED) achieve blood concentration similar to the brand AED. However, controversies exist about efficacy and safety of substituting generic AEDs. Because even minor absorption and kinetic differences can elicit a breakthrough seizure in patients who are changed to a generic AED from brand AED. Therefore, more ideal evaluation of interchangeability from the brand AEDs to generic formulation of the same drug is three-way or four-way crossover study, which can evaluate within-subject variability in pharmacokinetic and pharmacodynamic. Investigator designed four-way crossover study aimed to assess bioequivalence of brand and generic topiramate, to measure trough serum level , and to evaluate efficacy, tolerability and side effect of generic topiramate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacokinetic study, topamed | Active Comparator | For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in first visit day. For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in second visit day. For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in third visit day. For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in third visit day. |
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| Pharmacokinetic study, topamax | Active Comparator | For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in first visit day. For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in second visit day. For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in third visit day. For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in third visit day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacokinetic study | Procedure | Patients who are examen pharmacokinetic study after taking Topamax or Topiramate during 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Measure the Area under the plasma concentration versus time curve, serum trough drug level of generic and brand topiramate through pharmacokinetics study. | All comparisons of the drug formulations fulfill the bioequivalence criteria, with all 90% Confidential intervals(CIs) for Cmax, AUC, and Ctrough being within the 80-125% acceptance range. Scaling average bioequivalence that the acceptable bioequivalence limits of 90% CI of generic to brand topiramate will be those limits that are within and/or similar to the bioequivalence limits of the 90% CI of Brand to Brand topiramate | [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after taking the brand or generic topiramate during 7 days] |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability of generic topiramate in subjects with epilepsy | 4weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kon Chu, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20384761 | Background | Bialer M, Midha KK. Generic products of antiepileptic drugs: a perspective on bioequivalence and interchangeability. Epilepsia. 2010 Jun;51(6):941-50. doi: 10.1111/j.1528-1167.2010.02573.x. Epub 2010 Apr 8. | |
| 21692778 | Background | Erickson SC, Le L, Ramsey SD, Solow BK, Zakharyan A, Stockl KM, Harada AS, Curtis B. Clinical and pharmacy utilization outcomes with brand to generic antiepileptic switches in patients with epilepsy. Epilepsia. 2011 Jul;52(7):1365-71. doi: 10.1111/j.1528-1167.2011.03130.x. Epub 2011 Jun 21. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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