Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

Roxane Laboratories

Status and phase: Completed; Phase 1

Conditions: Seizures

Treatments: Drug: Oxcarbazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01703468

OXCA-S600-PVFD-2

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Oxcarbazepine then Trileptal

Active Comparator group

Description:

600 mg suspension

Treatment:

Drug: Oxcarbazepine

Trileptal then Oxcarbazepine

Active Comparator group

Description:

600 mg suspension

Treatment:

Drug: Oxcarbazepine