Overview

This trial is active, not recruiting.

Condition epilepsy
Treatment pharmacokinetic study
Phase phase 4
Sponsor Seoul National University Hospital
Start date February 2014
End date September 2016
Trial size 24 participants
Trial identifier NCT02113787, 0620140190 (2013-2172)

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
pharmacokinetic study
Patients who are examen pharmacokinetic study after taking Topamax or Topiramate during 7 days
(Active Comparator)
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.
pharmacokinetic study
Patients who are examen pharmacokinetic study after taking Topamax or Topiramate during 7 days

Primary Outcomes

Measure
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]

Secondary Outcomes

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

Eligibility Criteria

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.)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.