Switchability Study Between Brand and Generic Topiramate

Seoul National University

Status: Completed

Conditions: Epilepsy

Treatments: Procedure: Pharmacokinetic study

Study type: Interventional

Funder types: Other

Identifiers

NCT02113787

0620140190 (2013-2172)

Details and patient eligibility

About

The purpose of the study is to prove the bioequivalence of brand and generic topiramate.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Pharmacokinetic study, topamed

Active Comparator group

Description:

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.

Treatment:

Procedure: Pharmacokinetic study

Pharmacokinetic study, topamax

Active Comparator group

Description:

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.

Treatment:

Procedure: Pharmacokinetic study