NCT01678976

Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single 900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a single 900 mg dose of BIA 2-093 and Oxcarbazepine.

Detailed description

Single centre, open label, balanced randomised, two-way crossover study in 12 healthy volunteers. The study consisted of 2 periods separated by a washout period of 7 days or more. On each of the study periods the volunteers received either a single 900 mg oral dose of BIA 2-093 or a single 900 mg oral dose of Oxcarbazepine.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093	Tablets containing BIA 2-093 in doses of 300 and 600 mg
DRUG	Oxcarbazepine	Tablets containing 300 mg and 600 mg of Trileptal®

Timeline

• Start date: 2002-03-01
• Primary completion: 2002-04-01
• Completion: 2002-04-01
• First posted: 2012-09-05
• Last updated: 2015-01-08
• Results posted: 2015-01-08

Locations

1 site across 1 country: Portugal