NCT01702623
Completed
Phase 1
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
Overview
- Phase
- Phase 1
- Intervention
- Oxcarbazepine
- Conditions
- Seizures
- Sponsor
- Roxane Laboratories
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- bioequivalence determined by statistical comparison Cmax
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fasted conditions.
Investigators
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 first, then Trileptal
Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period)
Intervention: Oxcarbazepine
Trileptal first, then Oxcarbazepine
Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period
Intervention: Oxcarbazepine
Outcomes
Primary Outcomes
bioequivalence determined by statistical comparison Cmax
Time Frame: 10 Days
Study Sites (1)
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