Conditions: Renal Insufficiency
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 42
Healthy volunteers: yes

Brief summary:
The steady-state pharmacokinetics of Dalfampridine-ER (extended release) 7.5 mg (milligram) tablets in healthy adult volunteers and those with mild and moderate renal impairment, and examine between group comparisons.

Detailed description:
Pharmacokinetics in normal, mildly renally impaired, and moderately renally impaired subjects

Arms:
arm 1: Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers arm 2: Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment arm 3: Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment

Interventions: intervention 1: Dalfampridine-ER
Intervention descriptions: intervention 1: 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up

Protocol document: