---
title: Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions
nct_id: NCT00616681
overall_status: COMPLETED
phase: NA
sponsor: Roxane Laboratories
study_type: INTERVENTIONAL
primary_condition: Seizures
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00616681.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00616681"
ct_last_update_post_date: 2018-01-23
last_seen_at: "2026-05-12T06:30:04.313Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

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

**NCT ID:** [NCT00616681](https://clinicaltrials.gov/study/NCT00616681)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 28
- **Lead Sponsor:** Roxane Laboratories
- **Conditions:** Seizures, Epilepsy
- **Start Date:** 2004-06
- **Completion Date:** 2004-07
- **CT.gov Last Update:** 2018-01-23

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** ALL
- **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.
```

## Interventions

- **Oxcarbazepine** (DRUG)

## Primary Outcomes

- **Bioequivalence** _(time frame: Baseline, Two period, 7 day washout)_

## Locations (1)

- MDS Pharma Services, Montreal, Quebec, Canada

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mds pharma services|montreal|quebec|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00616681.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00616681*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*