Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions - Tabular View

Tracking Information

First Received Date ^ICMJE

February 4, 2008

Last Updated Date

February 14, 2008

Start Date ^ICMJE

June 2004

Primary Completion Date

July 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bioequivalence [ Time Frame: Baseline, Two period, 7 day washout ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00616681 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Condition ^ICMJE

Seizures
Epilepsy

Intervention ^ICMJE

Drug: Oxcarbazepine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2004

Primary Completion Date

July 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00616681

Responsible Party

Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.

Study ID Numbers ^ICMJE

OXCA-01

Study Sponsor ^ICMJE

Roxane Laboratories

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Gaetano Morelli, MD

MDS Pharma Services

Information Provided By

Roxane Laboratories

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP