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Switchability Study Between Brand and Generic Topiramate

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Pharmacokinetic study (Procedure)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Kon Chu, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To Measure the Area under the plasma concentration versus time curve, serum trough drug level of generic and brand topiramate through pharmacokinetics study.

Secondary outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability of generic topiramate in subjects with epilepsy

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.)

Locations and Contacts

Seoul National University Hospital, Seoul, Korea, Republic of
Additional Information

Related publications:

Bialer M, Midha KK. Generic products of antiepileptic drugs: a perspective on bioequivalence and interchangeability. Epilepsia. 2010 Jun;51(6):941-50. doi: 10.1111/j.1528-1167.2010.02573.x. Epub 2010 Apr 8. Review.

Erickson SC, Le L, Ramsey SD, Solow BK, Zakharyan A, Stockl KM, Harada AS, Curtis B. Clinical and pharmacy utilization outcomes with brand to generic antiepileptic switches in patients with epilepsy. Epilepsia. 2011 Jul;52(7):1365-71. doi: 10.1111/j.1528-1167.2011.03130.x. Epub 2011 Jun 21.

Starting date: February 2014
Last updated: May 26, 2015

Page last updated: August 23, 2015

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