Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions

Completed · Phase 1

Conditions studied: Seizures

In brief

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

Key facts

Study ID

NCT01702623

Run by

Roxane Laboratories

People needed

64

Starts

2009-09-01

Expected to finish

2009-09-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

You may not qualify if…

• 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.

Where it is running

• Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research) — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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