title: Comparative bioavailability study with two chlorpropamide tablet formulations in healthy volunteers.
abstract: OBJECTIVE
  The aim of this study was the assessment of the bioequivalence of two formulations (250 mg tablet) of chlorpropamide (CAS 94-20-2) in 36 healthy volunteers of both sexes.
  
  
  METHODS
  The study was conducted using an open, randomized, two-period crossover design with a 3-week washout interval. Plasma samples were obtained over a 72-h period. Plasma chlorpropamide concentrations were analyzed by liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using multiple reaction monitoring (MRM). From the chlorpropamide plasma concentration vs time curves, the following pharmacokinetic parameters were obtained: AUC(0-72h), AUC(inf) and C(max).
  
  
  RESULTS
  The limit of quantification was 0.1 microg/mL for plasma chlorpropamide analysis. The geometric mean and respective 90 % confidence interval (CI) of Test/ Reference percent ratios were 93.99% (87.11%-101.41%) for C(max), 92.45% (85.96%-99.44%) for AUC(0-72h) and 90.30% (83.35%-97.82%) for AUC(0-inf).
  
  
  CONCLUSIONS
  Since the 90 % CI for AUC(0-72h), AUC(0-inf) and C(max) ratios were within the 80-125%interval proposed by the US FDA, it was concluded that chlorpropamide 250 mg tablet (test formulation) was bioequivalent to the reference 250 mg tablet for of both the rate and extent of absorption.
authors.affiliation: Department of Pharmacology, Faculty of Medical Sciences, State University of Campinas, Campinas, SP, Brazil.
authors.forename: Marcia Aparecida
authors.initials: MA
authors.lastname: da Silva
authors.forename: Fabiana D
authors.initials: FD
authors.lastname: Mendes
authors.forename: Rogério Antonio
authors.initials: RA
authors.lastname: de Oliveira
authors.forename: Tausif
authors.initials: T
authors.lastname: Monif
authors.forename: Anil
authors.initials: A
authors.lastname: Patni
authors.forename: Simrit
authors.initials: S
authors.lastname: Reyar
authors.forename: Gustavo D
authors.initials: GD
authors.lastname: Mendes
authors.forename: Gilberto
authors.initials: G
authors.lastname: De Nucci
mesh_terms: D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002747:Chlorpropamide / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D002853:Chromatography, Liquid; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D007408:Intestinal Absorption; D008297:Male; D021241:Spectrometry, Mass, Electrospray Ionization; D013607:Tablets; D053719:Tandem Mass Spectrometry
chemical_list: D007004:Hypoglycemic Agents; D013607:Tablets; D002747:Chlorpropamide