title: Pharmacokinetic and safety assessments of galantamine and risperidone after the two drugs are administered alone and together.
abstract: To explore the steady-state pharmacokinetic profile after coadministration of galantamine and risperidone, an open-label, randomized, single-center, two-way crossover drug-drug interaction study was conducted in 16 healthy elderly subjects, ages 60 years and older. The results showed that risperidone, when administered with galantamine, did not change the bioavailability of galantamine at steady state. In addition, systemic exposure of risperidone active moiety (risperidone plus 9-hydroxyrisperidone), the most clinically relevant component of risperidone treatment, was not affected by galantamine coadministration, while systemic exposure was increased by approximately 10% for risperidone and decreased by about 10% for 9-hydroxyrisperidone (active metabolite of risperidone). Galantamine and risperidone were both safe and well tolerated administered either alone or together. Thus, no dose adjustment for either risperidone orgalantamine is necessary when these two drugs are administered together in the dose range evaluated.
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, Titusville, New Jersey 08560, USA.
authors.forename: Fenglei
authors.initials: F
authors.lastname: Huang
authors.forename: Kenneth C
authors.initials: KC
authors.lastname: Lasseter
authors.forename: Luc
authors.initials: L
authors.lastname: Janssens
authors.forename: Tom
authors.initials: T
authors.lastname: Verhaeghe
authors.forename: Henry
authors.initials: H
authors.lastname: Lau
authors.forename: Qinying
authors.initials: Q
authors.lastname: Zhao
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002800:Cholinesterase Inhibitors / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004347:Drug Interactions; D005260:Female; D005702:Galantamine / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D008401:Gas Chromatography-Mass Spectrometry; D006801:Humans; D007555:Isoxazoles / Q000097:blood; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate; D011743:Pyrimidines / Q000097:blood; D018967:Risperidone / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D013997:Time Factors
chemical_list: D014150:Antipsychotic Agents; D002800:Cholinesterase Inhibitors; D007555:Isoxazoles; D011743:Pyrimidines; D005702:Galantamine; D018967:Risperidone; D000068882:Paliperidone Palmitate