As Study of the Pharmacokinetics of Paliperidone Extended-release and Risperidone Immediate-release Formulations
Status:
Completed
Trial end date:
2004-01-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare the steady-state pharmacokinetics of paliperidone
after oral administration of 15 mg extended-release (ER) OROS paliperidone once daily with
the steady-state pharmacokinetics of paliperidone after oral administration of 8 mg
immediate-release (IR) risperidone twice daily; and to explore the dose-proportionality of 9
mg and 15 mg ER OROS paliperidone. Other objectives are to 1) document the disposition of the
enantiomers of paliperidone; 2) explore the relationship between genotype (CYP2D6, CYP3A4,
CYP3A5, UGT1A1, and UGT1A6) and pharmacokinetic parameters; and 3) assess safety and
tolerability.
Phase:
Phase 1
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.