Skip to main content
OpenTrials
Completed

NCT Number: NCT00618046

Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Seizures Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bio-Kinetics Clinical Applications, Inc .

Springfield, Missouri, 658902, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxcarbazepine

Drug

Primary outcomes

  1. Bioequivalence

    Time frame: Baseline, Two Period, Seven day washout

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Feb 18, 2008
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.