Effects of Renal Impairment on the Pharmacokinetics of Once-Daily Amantadine Extended-Release Tablets.

ABSTRACT:

Background

An extended-release formulation of amantadine (Osmolex ER™, Osmotica Pharmaceutical US LLC) was approved in February 2018 to treat Parkinson's disease and drug-induced extrapyramidal reactions in adults.

Objectives

To determine the pharmacokinetic profile of extended-release amantadine in subjects with varying degrees of renal impairment.

Methods

Adults with normal renal function (creatinine clearance > 89 mL/min/1.73 m²), moderate renal impairment (creatinine clearance 30-59 mL/min/1.73 m²), or severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m²) received a single 129-mg dose (160 mg amantadine hydrochloride) of extended-release amantadine. Blood and urine samples for pharmacokinetic analysis w

SUBMITTER: deVries T 

PROVIDER: S-EPMC6669187 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature