Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

NCT ID: NCT00618046

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2004-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Seizures Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Oxcarbazepine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roxane Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Roxane Laboratories, Inc.

Principal Investigators

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Dennis Morrison, D.O.

Role: PRINCIPAL_INVESTIGATOR

Bio-Kinetic Clinical Applications, Inc.

Locations

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Bio-Kinetics Clinical Applications, Inc .

Springfield, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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OXCA-T600-PVFD-2

Identifier Type: -

Identifier Source: org_study_id

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