title: Bioequivalence of two lithium formulations in healthy volunteers.
abstract: OBJECTIVE
  The purpose of this study was to compare the maximum exposure and extent of bioavailability of two lithium carbonate (CAS 554-13-2) containing 300 mg tablet formulations (test and reference) for oral administration.
  
  
  METHODS
  This bioequivalence study was conducted in a 2-period crossover design with a washout phase of 7 days. Plasma samples were obtained by blood sampling over 72 h in each period. Twenty-four healthy volunteers of both genders participated in the trial. Samples were analyzed by a flame atomic absorption spectrometer. Resulting Li+ concentrations were used for determination of the pharmacokinetic parameters AUC(last), AUC(inf) and C(max).
  
  
  RESULTS
  90 % confidence intervals for AUC(last), AUC(inf) and C(max) were 96.81-107.44%, 98.44-109.54% and 98.60-111.33%, respectively.
  
  
  CONCLUSIONS
  All 90% and 95% confidence intervals were inside the limits defined by the FDA Guidance for Industry (80%-125%) and thus stated that test and reference formulation may be accepted as bioequivalent, with regard to both, maximum exposure and extent of bioavailability.
authors.affiliation: Galeno Research Unit, St. Campinas, Sao Paulo, Brazil.
authors.forename: Márcia Cristina
authors.initials: MC
authors.lastname: Guilherme
authors.forename: Dárcio Gomes
authors.initials: DG
authors.lastname: Pereira
authors.forename: Miriam Prado
authors.initials: MP
authors.lastname: Galuppo
authors.forename: Gustavo D
authors.initials: GD
authors.lastname: Mendes
authors.forename: José Luiz
authors.initials: JL
authors.lastname: Donato
authors.forename: Gilberto
authors.initials: G
authors.lastname: De Nucci
mesh_terms: D000328:Adult; D018692:Antimanic Agents / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016651:Lithium Carbonate / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D008875:Middle Aged; D011786:Quality Control; D013810:Therapeutic Equivalency
chemical_list: D018692:Antimanic Agents; D016651:Lithium Carbonate