Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions

Phase 1

Completed

• Conditions: Seizures
• Interventions: Drug: Oxcarbazepine

• Registration Number: NCT01702623
• Lead Sponsor: Roxane Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-05
• Study First Posted: 2012-10-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxcarbazepine first, then Trileptal	Oxcarbazepine	Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period)
Trileptal first, then Oxcarbazepine	Oxcarbazepine	Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax	10 Days

Trial Locations

Locations (1)

Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research); 🇺🇸 San Antonio, Texas, United States