Switchability Study Between Brand and Generic Topiramate

September 23, 2021 updated by: Kon Chu, Seoul National University Hospital

A Clinical Pharmacokinetics Comparing Brand and Generic Topiramate in Epilepsy Patients : A Open-label,Randomised, Three-period Crossover Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Procedure: Pharmacokinetic study
Patients who are examen pharmacokinetic study after taking Topamax or Topiramate during 7 days
ACTIVE_COMPARATOR: 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.
Procedure: Pharmacokinetic study
Patients who are examen pharmacokinetic study after taking Topamax or Topiramate during 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
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]

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]

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of generic topiramate in subjects with epilepsy
Time Frame: 4weeks
4weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (ESTIMATE)

April 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0620140190 (2013-2172)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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