Conditions: Epilepsy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: yes

Brief summary:
Open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of subjects with various degrees of renal function based on creatinine clearance

Detailed description:
This was an open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of subjects with various degrees of renal function based on creatinine clearance (stages of renal function according to the Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products Guidelines) for the evaluation of pharmacokinetics in patients with impaired renal function.

The trial commenced with Groups 1 and 2. An interim safety evaluation was conducted and, as there were no safety concerns, the trial continued with Groups 3 and 4. After another interim safety evaluation with the data from Groups 3 and 4, the trial commenced with Group 5.

Arms:
arm 1: normal renal function (creatinine clearance \> 80 mL/min) arm 2: mild renal impairment (creatinine clearance 50-80 mL/min) arm 3: moderate renal impairment (creatinine clearance 30-50 mL/min) arm 4: severe renal impairment (creatinine clearance \<30 mL/min) arm 5: end stage renal disease, requiring haemodialysis (ESRD)

Interventions: intervention 1: BIA 2-093
Intervention descriptions: intervention 1: None

Protocol document: