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Switchability Study Between Brand and Generic Topiramate

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ClinicalTrials.gov Identifier: NCT02113787
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Kon Chu, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Epilepsy Procedure: Pharmacokinetic study Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Pharmacokinetics Comparing Brand and Generic Topiramate in Epilepsy Patients : A Open-label,Randomised, Three-period Crossover Study
Study Start Date : February 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Topiramate

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




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability of generic topiramate in subjects with epilepsy [ Time Frame: 4weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113787


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Kon Chu, MD, PhD Seoul National University Hospital

Publications:
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Responsible Party: Kon Chu, MD,PhD, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02113787     History of Changes
Other Study ID Numbers: 0620140190 (2013-2172)
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Keywords provided by Kon Chu, Seoul National University Hospital:
epilepsy
anticonvulsants
generic drugs
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs