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NCT01703468 Clinical Trial

Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01703468
Other study ID # OXCA-S600-PVFD-2
Secondary ID
Status Completed
Phase Phase 1
First received October 5, 2012
Last updated January 19, 2018
Start date September 2009
Est. completion date October 2009

Study information
Verified date January 2018
Source West-Ward Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date October 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oxcarbazepine

Locations
Country Name City State
United States Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research) San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary bioequivalence determined by statistical comparison Cmax Blood sampling taken during specified time points to determine bioequivalence 10 days
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