title: Bioequivalence study of 2 orodispersible formulations of ondansetron 8 mg in healthy volunteers.
abstract: This study was designed to compare the rate and extent of absorption of 2 oral formulations of ondansetron (CAS 99614-02-5) 8 mg orodispersible tablets in healthy volunteers. 22 subjects were administered ondansetron orodispersible tablets of test and reference formulation in a single-dose, 2-period, 2-sequence, fasting, open-label, crossover and randomised study. Plasma concentrations were determined by LC/MS/MS. Log-transformed AUCs and Cmax values were tested for bioequivalence based on the ratios of the geometric means (test/reference). Tmax was analysed nonparametrically. The 90% confidence intervals of the geometric mean values for the test/reference ratios for AUC0-t and Cmax were within the bioequivalence acceptance range of 80-125%. According to the European Guideline [1] it may be therefore concluded that test formulation of ondansetron 8 mg orodispersible tablet is bioequivalent to the reference formulation.
authors.affiliation: Laboratorios Lesvi, S. L.- Invent Farma Group, Sant Joan Despí, Barcelona, Spain. mcanovas@lesvi.com
authors.forename: M
authors.initials: M
authors.lastname: Cánovas
authors.forename: J
authors.initials: J
authors.lastname: Rios
authors.forename: G
authors.initials: G
authors.lastname: Domenech
authors.forename: J
authors.initials: J
authors.lastname: Cebrecos
authors.forename: P
authors.initials: P
authors.lastname: Pelagio
authors.forename: M
authors.initials: M
authors.lastname: Canals
authors.forename: F
authors.initials: F
authors.lastname: Polonio
authors.forename: F
authors.initials: F
authors.lastname: Cabré
mesh_terms: D000293:Adolescent; D000328:Adult; D000932:Antiemetics / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006207:Half-Life; D006801:Humans; D008297:Male; D017294:Ondansetron / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D018401:Sample Size; D053719:Tandem Mass Spectrometry; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D000932:Antiemetics; D017294:Ondansetron