NCT02113787

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

3.1 years

First QC Date

March 19, 2014

Last Update Submit

September 23, 2021

Conditions

Epilepsy

Keywords

epilepsyanticonvulsantsgeneric drugs

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (1)

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

    4weeks

Study Arms (2)

Pharmacokinetic study, topamed

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.

Procedure: Pharmacokinetic study

Pharmacokinetic study, topamax

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.

Procedure: Pharmacokinetic study

Interventions

Pharmacokinetic studyPROCEDURE

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

Pharmacokinetic study, topamaxPharmacokinetic study, topamed

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18-65 years
  • Patients with epilepsy who take by topamax 100mg bid or who need to take topamax 100mg bid

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 20384761BACKGROUND

  • 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.

    PMID: 21692778BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kon Chu, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD, professor

Study Record Dates

First Submitted

March 19, 2014

First Posted

April 15, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

KR(1)