NCT01679002

Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in healthy subjects.

Detailed description

Single centre, open-label, randomised, three-way crossover study in 12 healthy volunteers. The study consisted of three 8-day treatment periods separated by washout periods of 10-15 days. On each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 900 mg once-daily (od), BIA 2-093 450 mg twice-daily (bid), or Oxcarbazepine (Trileptal®) 450 mg bid.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093
DRUG	Oxcarbazepine

Timeline

• Start date: 2003-10-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2012-09-05
• Last updated: 2025-04-06
• Results posted: 2015-01-01

Locations

1 site across 1 country: Portugal