title: Comparative pharmacokinetic and pharmacodynamic evaluation of branded and generic formulations of meloxicam in healthy male volunteers.
abstract: OBJECTIVE
  The primary aim of the present study was to assess the pharmacokinetic bioequivalence between a generic formulation of meloxicam 15 mg tablets (Meloxicam Hexal) and its respective brand product (Mobic), in order to verify whether the generic product conforms to the regulatory standards of bioequivalence in the postmarketing setting. As a secondary exploratory aim, the pharmacodynamic effects of the two formulations were also evaluated by means of rating scales following hyperalgesia induced by cutaneous freeze injury.
  
  
  METHODS
  A single 15 mg dose of generic or branded meloxicam tablets was administered to 24 healthy male volunteers in a crossover fashion. Plasma samples, collected for 24 hours after dosing, were assayed for meloxicam concentration by a validated highperformance liquid chromatography method.
  
  
  RESULTS
  THE ANALYSIS OF PHARMACOKINETIC PARAMETERS DID NOT SHOW ANY SIGNIFICANT DIFFERENCE BETWEEN THE TWO MELOXICAM FORMULATIONS: the 90% confidence intervals fell within the acceptance range of 80%-125% (0.84-1.16 for area under the curve [0-24], and 0.89-1.23 for peak concentration). No difference in the pharmacodynamic end point was observed between the two groups.
  
  
  CONCLUSIONS
  The pharmacokinetic profiles of the two meloxicam formulations confirm the regulatory criteria for bioequivalence; pharmacodynamic data indicate a similar antihyperalgesic effect. The two formulations can be used interchangeably in the clinical setting.
authors.affiliation: Clinical Pharmacology Centre for Drug Experimentation, Pisa University Hospital, Pisa, Italy ; Department of Clinical and Experimental Medicine, Pisa, Italy.
authors.forename: Mario Del
authors.initials: MD
authors.lastname: Tacca
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pasqualetti
authors.forename: Giovanni
authors.initials: G
authors.lastname: Gori
authors.forename: Pasquale
authors.initials: P
authors.lastname: Pepe
authors.forename: Antonello
authors.initials: A
authors.lastname: Di Paolo
authors.forename: Marianna
authors.initials: M
authors.lastname: Lastella
authors.forename: Ferdinando
authors.initials: F
authors.lastname: De Negri
authors.forename: Corrado
authors.initials: C
authors.lastname: Blandizzi
keywords: bioequivalence; generic drug; healthy volunteers; meloxicam; pharmacokinetics; postmarketing
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