Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fasting Conditions

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616681

Enrollment

Registered

2008-02-15

Start date

2004-06-30

Completion date

2004-07-31

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 the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose administered under fasting conditions.

Interventions

DRUGOxcarbazepine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* No clinically significant abnormal finding on the physical examination, medical history, or clinical labratory results duirng screening

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Bioequivalence	Baseline, Two period, 7 day washout

Countries

Canada

Outcome results

None listed

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