Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Roxane Laboratories48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Seizures Epilepsy

Interventions

OxcarbazepineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bio-Kinetics Clinical Applications, Inc .

Springfield, Missouri, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, Two Period, Seven day washout

Data from ClinicalTrials.gov

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