Switchability Study Between Brand and Generic Topiramate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pharmacokinetic study, topamed

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.

Group Type ACTIVE_COMPARATOR

Pharmacokinetic study

Intervention Type PROCEDURE

Patients who are examen pharmacokinetic study after taking Topamax or Topiramate during 7 days

Pharmacokinetic study, topamax

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.

Group Type ACTIVE_COMPARATOR

Pharmacokinetic study

Intervention Type PROCEDURE

Patients who are examen pharmacokinetic study after taking Topamax or Topiramate during 7 days

Interventions

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Pharmacokinetic study

Patients who are examen pharmacokinetic study after taking Topamax or Topiramate during 7 days

Intervention Type PROCEDURE

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No