Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Trileptal®; Drug: Oxcarbazepine

• Registration Number: NCT00849797
• Lead Sponsor: Teva Pharmaceuticals USA

Brief Summary

The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed conditions.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-24
• Results First Submitted: 2009-07-02
• Results First Submitted QC: 2009-07-02
• Results First Posted: 2009-08-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Trileptal®	Trileptal®	Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
Oxcarbazepine	Oxcarbazepine	Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period

Primary Outcome Measures

Name	Time	Method
Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma	Blood samples collected over 48 hour period	Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine	Blood samples collected over 48 hour period	Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine	Blood samples collected over 48 hour period	Bioequivalence based on AUC0-t

Secondary Outcome Measures

Name	Time	Method
AUC0-t - 10-Hydroxy-Carbazepine Metabolite	Blood samples collected over 48 hour period	Informational Purposes Only
Cmax - 10-hydroxy-carbazepine in Plasma	Blood samples collected over 48 hour period	Informational Purposes Only
AUC0-inf - 10-Hydroxy-Carbazepine Metabolite	Blood samples collected over 48 hour period	Informational Purposes Only

Trial Locations

Locations (1)

SFBC Anapharm; 🇨🇦 Montreal, Quebec, Canada