NCT00618046

Brief Summary

The objective of this study was to assess bioequivalence of a potential generic 600 mb oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose, administered with food.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2004

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

November 1, 2004

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

January 31, 2008

Last Update Submit

January 19, 2018

Conditions

SeizuresEpilepsy

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence

    Baseline, Two Period, Seven day washout

Interventions

OxcarbazepineDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at screening.

You may not qualify if:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with any known enzyme altering drugs.
  • History of allergic or adverse response to oxcarbazepine or any other comparable or similar product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bio-Kinetics Clinical Applications, Inc .

Springfield, Missouri, 658902, United States

Location

MeSH Terms

Conditions

SeizuresEpilepsy

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

CarbamazepineDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Dennis Morrison, D.O.

    Bio-Kinetic Clinical Applications, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 18, 2008

Study Start

November 1, 2004

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)