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Clinical Trials/NCT01703468
NCT01703468
Completed
Phase 1

A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

Roxane Laboratories1 site in 1 country59 target enrollmentSeptember 2009
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ConditionsSeizures
InterventionsOxcarbazepine
DrugsOxcarbazepine

Overview

Phase
Phase 1
Intervention
Oxcarbazepine
Conditions
Seizures
Sponsor
Roxane Laboratories
Enrollment
59
Locations
1
Primary Endpoint
bioequivalence determined by statistical comparison Cmax
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fed conditions

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
October 2009
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •No clinically significant abnormal findings 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 adverse response to oxcarbazepine or any comparable or similar product.

Arms & Interventions

Oxcarbazepine then Trileptal

600 mg suspension

Intervention: Oxcarbazepine

Trileptal then Oxcarbazepine

600 mg suspension

Intervention: Oxcarbazepine

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax

Time Frame: 10 days

Blood sampling taken during specified time points to determine bioequivalence

Study Sites (1)

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