NCT00618046: Oxcarbazepine tablet bioequivalence with food

Medicine Signal Editorial Desk
Updated 2026-10-10

Registry status when checked 2026-10-10Completed

Study: Fed-state bioequivalence of a Roxane Laboratories oxcarbazepine 600-mg tablet against Trileptal. 1 2

Design and measurements: The registry describes a randomized, open-label, two-treatment, two-period crossover study with 48 actual participants. Each formulation was administered as a single dose with food, allowing within-participant comparison of drug-exposure measurements. 1 2

What is established: The record is completed, with a January 2018 update. Numerical exposure ratios and their confidence intervals were not verified, so completed status alone cannot establish that the prespecified bioequivalence criteria were met. This study concerns formulation pharmacokinetics under fed conditions, not a new clinical comparison of seizure prevention or a recommendation to change an individual's medication. 1 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00618046. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00618046. Original study registration: sponsor, design, population, endpoints and dated history.

2. ICH GCP — ICH GCP — readable reproduction of the sponsor-submitted ClinicalTrials.gov record. Supports the registration details quoted here; not an independent clinical-results publication.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.