A Study of the Pharmacokinetics of ER OROS Paliperidone in Volunteers With Normal or Impaired Renal Function
Status:
Completed
Trial end date:
2005-02-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of 3 mg
extended release paliperidone (ER OROSÃ' paliperidone) in patients with varying degrees of
renal impairment (mild, moderate, and severe), compared to patients with normal renal
function. Secondary objectives include the assessing the disposition of the (+) and (-)
enantiomers by means of an enantioselective liquid chromatography mass spectrometry assay, to
determine plasma protein binding of the enantiomers in patients with impaired renal function,
compared with patients with normal renal function, and to evaluate the tolerability and
safety profile of ER OROS paliperidone in patients with varying degrees of renal impairment
(mild, moderate, and severe) compared with patients with normal renal function.
Phase:
Phase 1
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.