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Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy; Seizures

Intervention: Oxcarbazepine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Roxane Laboratories

Official(s) and/or principal investigator(s):
Gaetano Morrelli, MD, Principal Investigator, Affiliation: MDS Pharma Services

Summary

The objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, folloiwng a single 600 mg dose administered with food.

Clinical Details

Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazapine 600 mg Tablets Under Fed Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- No clinically significant abnormal finding on the physical examination, medical

history, or clinical laboratory results during screening. Exclusion Criteria:

- Positive test for HIV, Hepatitis B, or Hepatitis C.

- Treatment with known enzyme altering drugs.

- History of allergic or advers response to oxcarbazepine or any other comparable or

similar product.

Locations and Contacts

MDS Pharma Services, Montreal, Quebec H4R 2N6, Canada
Additional Information

Starting date: July 2004
Last updated: February 14, 2008

Page last updated: August 23, 2015

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