Switchability Study Between Brand and Generic Topiramate
Switchability Study Between Brand and Generic Topiramate
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.
Inclusion Criteria:

 -  aged 18-65 years

 -  Patients with epilepsy who take by topamax 100mg bid or who need to take topamax 100mg
 bid

 Exclusion Criteria:

 -  poor compliance

 -  subjects whose dose of antiepileptic drug are changed during the study

 -  subjects whose seizure is not well-controlled judged by neurologist

 -  history of any kind of drug allergy

 -  pregnancy or nursing

 -  existing or recent significant disease (cardiac, hepatic, or renal disease, severe
 diabetes mellitus, sepsis, etc.)