title: Comparative bioavailability of two risperidone orodispersible tablet products after single dose administration.
abstract: OBJECTIVE
  To compare the bioavailability of two risperidone orodispersible tablet products, Risperidone 1 mg Mouth dissolving tablet, Ranbaxy (Malaysia) Sdn. Bhd., Malaysia, as a test product and Risperdal 1 mg Quicklet, Janssen Ortho LLC, Gurabo, Puerto Rico, as a reference product, in healthy male volunteers under fasting condition.
  
  
  METHODS
  A randomized, 2-treatment, 2-period, 2-sequence, single dose, crossover with a washout period of 2 weeks, was conducted in 24 healthy Thai male volunteers. Blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h following drug administration. Plasma concentrations of risperidone and 9-hydroxyrisperidone were determined using a validated LC-MS-MS method. The pharmacokinetic parameters of risperidone and 9-hydroxyrisperidone were determined using a non-compartmental model.
  
  
  RESULTS
  The geometric means ratios (%) and 90% confidence interval (CI) of the test and reference products for the log-transformed pharmacokinetic parameters, Cmax, AUC0-t and AUC0-inf of risperidone were 104.49 % (92.79% - 117.66%), 100.96 % (92.15% - 110.61 %) and 97.99 % (90.72% - 105.85%). The 90% CI of geometric means ratios of the test and reference products for the log-transformed pharmacokinetic parameters, Cmax, AUC0-t and AUC0-inf of 9-hydroxyrisperidone were 97.00%, 96.97% and 97.49%.
  
  
  CONCLUSIONS
  The 90% CI for the geometric means ratios (test/reference) of the log-trasformed Cmax, AUC0-t and AUC0-inf of risperidone and its major active metabolite were within the bioequivalence acceptance criteria of 80% - 125% of the US-FDA.
authors.affiliation: Department of Pharmacology, Khon Kaen University, Thailand. wichitt@kku.ac.th
authors.forename: W
authors.initials: W
authors.lastname: Tassaneeyakul
authors.forename: S
authors.initials: S
authors.lastname: Kumar
authors.forename: D
authors.initials: D
authors.lastname: Gaysonsiri
authors.forename: T
authors.initials: T
authors.lastname: Kaewkamson
authors.forename: A
authors.initials: A
authors.lastname: Khuroo
authors.forename: P
authors.initials: P
authors.lastname: Tangsucharit
authors.forename: K
authors.initials: K
authors.lastname: Phunikhom
authors.forename: S
authors.initials: S
authors.lastname: Vannaprasaht
authors.forename: S
authors.initials: S
authors.lastname: Kanjanawart
authors.forename: N
authors.initials: N
authors.lastname: Rao Thudi
authors.forename: R
authors.initials: R
authors.lastname: Jain
authors.forename: S
authors.initials: S
authors.lastname: Reyar
authors.forename: T
authors.initials: T
authors.lastname: Monif
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D018967:Risperidone / Q000493:pharmacokinetics*; D013607:Tablets; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D013607:Tablets; D018967:Risperidone