Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00618046

Enrollment

Registered

2008-02-18

Start date

2004-11-30

Completion date

2004-11-30

Last updated

2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Seizures

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.

Interventions

DRUGOxcarbazepine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence	Baseline, Two Period, Seven day washout

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026