NCT02281526

An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093

An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093 in Subjects With Moderate Hepatic Impairment.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls. The trial consisted of a screening visit, a treatment phase and a follow-up visit. All subjects were to be treated with study medication for 8 consecutive days. Blood and urine were collected for the PK analysis, and safety assessments were performed.

Detailed description

The screening visit was performed 2 to 21 days before the first administration of study medication, the treatment phase consisted of 12 days (of which study medication was administered during the first 8 days), and the follow-up visit was performed 15 to 19 days after the first administration of study medication.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093

Timeline

• Start date: 2005-05-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2014-11-03
• Last updated: 2015-01-12
• Results posted: 2015-01-12

Locations

1 site across 1 country: South Africa