Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616681
• Other study ID #: OXCA-01
• Status: Completed
• Phase: N/A
• First received: February 4, 2008
• Last updated: January 19, 2018
• Start date: June 2004
• Est. completion date: July 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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 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.

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• Oxcarbazepine

Locations

Country	Name	City	State
Canada	MDS Pharma Services	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence		Baseline, Two period, 7 day washout