At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 17 enrolled
Drug / intervention
BIA 2-093drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093 in Subjects With Moderate Hepatic Impairment.
In Brief
A Phase 1 clinical trial evaluating BIA 2-093 for Epilepsy. Completed, enrolled 17 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesSouth Africa
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
Primary CompletionFeb 2006
First PostedNov 2014
TodayJul 2026
First PostedNov 3, 2014
Enrollment StartMay 1, 2005
Primary CompletionFeb 1, 2006
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.7 years ago
Interventions
BIA 2-093drug