title: Bioequivalence study of a novel orodispersible tablet of meloxicam in a porous matrix after single-dose administration in healthy volunteers.
abstract: BACKGROUND
  Meloxicam is a non-steroidal anti-inflammatory drug, indicated for osteoarthritis exacerbations, rheumatoid arthritis and ankylosing spondylitis symptomatic treatment.
  
  
  OBJECTIVE
  To compare the bioavailability of a 15 mg meloxicam orodispersible tablet (ODT) and a reference 15 mg tablet in healthy volunteers.
  
  
  METHODS
  Two randomized, crossover, bioequivalence studies were conducted. In both studies, 28 volunteers were randomly assigned to receive test ODT and reference tablet formulations in single dose under fasting conditions in two study periods, with a 7-day (Study I) or 14-day (Study II) wash-out between administrations. Blood samples were collected at pre-specified times. Pharmacokinetic parameters were obtained by noncompartmental analysis. Bioequivalence was assumed if the 90% confidence interval of the test/reference ratio of the least-squares means for Cmax, AUC0-t and AUC0-∞were within the 80.00 -125.00% range, according to the current guidelines.
  
  
  RESULTS
  All 28 subjects in Study I and 26 subjects in study II completed the study and were included in the analysis. The 90% confidence intervals of the geometric means ratios for the logtransformed Cmax, AUC0-t and AUC0-∞were 87 - 96%, 88 - 96% and 87 - 96% in Study I, and 99 - 105%, 98 - 104% and 108 - 120% in Study II. Test product was characterized by a slightly earlier tmax than the reference, i.e., 4.9 ± 1.1 vs. 5.8 ± 2.6 hours in Study I (p = 1.000) and 3.8 ± 2.0 vs. 4.8 ±1.6 hours in Study II (p = 0.0054). The two drugs were well tolerated.
  
  
  CONCLUSIONS
  Test and reference formulations met the regulatory criteria for bioequivalence in the fasting healthy volunteers enrolled.
authors: CROSS Research , Arzo, Switzerland.
authors: Milko
authors: M
authors: Radicioni
authors: Sandra
authors: S
authors: Connolly
authors: Federico
authors: F
authors: Stroppolo
authors: Gabriele
authors: G
authors: Granata
authors: Luca
authors: L
authors: Loprete
authors: Chiara
authors: C
authors: Leuratti
mesh_terms: D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000493:pharmacokinetics*; D019540:Area Under Curve; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D000077239:Meloxicam; D008875:Middle Aged; D016062:Porosity; D012995:Solubility; D013607:Tablets; D013810:Therapeutic Equivalency; D013843:Thiazines / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D013844:Thiazoles / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D013607:Tablets; D013843:Thiazines; D013844:Thiazoles; D000077239:Meloxicam