Switchability Study Between Brand and Generic Topiramate
This trial is active, not recruiting.
|Sponsor||Seoul National University Hospital|
|Start date||February 2014|
|End date||September 2016|
|Trial size||24 participants|
|Trial identifier||NCT02113787, 0620140190 (2013-2172)|
The purpose of the study is to prove the bioequivalence of brand and generic topiramate.
|Endpoint classification||bio-equivalence study|
|Intervention model||crossover assignment|
To Measure the Area under the plasma concentration versus time curve, serum trough drug level of generic and brand topiramate through pharmacokinetics study.
time frame: [ 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]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of generic topiramate in subjects with epilepsy
time frame: 4weeks
Male or female participants from 18 years up to 65 years old.
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.)
|Official title||A Clinical Pharmacokinetics Comparing Brand and Generic Topiramate in Epilepsy Patients : A Open-label,Randomised, Three-period Crossover Study|
|Principal investigator||Kon Chu, MD, PhD|
|Description||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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