Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618046
• Other study ID #: OXCA-T600-PVFD-2
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: January 19, 2018
• Start date: November 2004
• Est. completion date: November 2004

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• Oxcarbazepine

Locations

Country	Name	City	State
United States	Bio-Kinetics Clinical Applications, Inc .	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence		Baseline, Two Period, Seven day washout