DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



The influence of hepatic impairment on the pharmacokinetics of paliperidone.

Author(s): Boom S, Thyssen A, Crauwels H, Molz KH, Cleton A, Janssens L, Talluri K, Eerdekens M

Affiliation(s): Johnson & Johnson Pharmaceutical Research & Development, Beerse, Belgium.

Publication date & source: 2009-10, Int J Clin Pharmacol Ther., 47(10):606-16.

Publication type: Controlled Clinical Trial; Research Support, Non-U.S. Gov't

OBJECTIVES: This study assessed the impact of hepatic impairment on the pharmacokinetics (PK) of paliperidone and its enantiomers. METHODS: A single 1 mg dose of paliperidone immediate-release (IR) was administered to subjects with moderate hepatic impairment (n = 10) and demographically matched individuals with normal hepatic function (n = 10). RESULTS: Plasma protein binding was lower in hepatically impaired subjects resulting in a 27% higher unbound fraction of paliperidone compared with healthy individuals. After correcting for the difference in plasma protein binding, unbound exposures were comparable between groups. All other PK parameters were similar between the two groups. Paliperidone IR was equally well tolerated in both groups. CONCLUSIONS: The impact of moderate hepatic impairment on paliperidone PK is not considered clinically relevant as the PK profile of unbound paliperidone is similar for subjects with moderate hepatic impairment and those with normal hepatic function. Dosage adjustments of paliperidone are not required in subjects with mild or moderate hepatic impairment.

Page last updated: 2010-10-05

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017