NCT01316055

Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment

A Parallel, Three Arm, Open-label, Multi-dose Pharmacokinetic Study of Dalfampridine-ER 7.5 mg Twice Daily in Both Healthy Volunteers and Those With Mild and Moderate Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Dalfampridine-ER	2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2011-03-16
• Last updated: 2012-11-07
• Results posted: 2012-11-07

Locations

2 sites across 1 country: United States