Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00616681
• Date of registration: 04/02/2008
• Primary sponsor: Roxane Laboratories
• Public title: Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions
• Scientific title: A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fasting Conditions
• Date of first enrolment: June 2004
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00616681
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: Gaetano Morelli, MD
• Affiliation: MDS Pharma Services

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Epilepsy

Seizures

Intervention(s)

Drug: Oxcarbazepine

Primary Outcome(s)

Bioequivalence [Time Frame: Baseline, Two period, 7 day washout]

Secondary ID(s)

OXCA-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors