title: Bioequivalence study of two commercial amoxicillin suspension formulations in healthy human volunteers.
abstract: OBJECTIVE
  To compare the pharmacokinetic profiles and to evaluate the bioequivalence of two commercial amoxicillin suspension formulations (500 mg/5 mL AMOXIL®, reference formulation and AMOXI-PED®, test formulation) in healthy Brazilian volunteers.
  
  
  METHODS
  Under fasting condition, 25 volunteers (13 males and 12 females) were included in this randomized, open-label, two-period crossover (1-week washout interval) bioequivalence study. Blood samples were collected at pre-dose (0 hour) and 0.5, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 12 hours after drug ingestion. Pharmacokinetic parameters (Cmax, tmax, t1/2, AUC0-tlast, and AUC0-∞) were calculated from plasma concentrations for both formulations in each subject.
  
  
  RESULTS
  Arithmetic mean values of the pharmacokinetic parameters were: Cmax = 12.004 (± 2.824) μg×mL-1; tmax = 1.118 (± 0.396) h; t1/2 = 1.226 (± 0.179) h; AUC0-tlast = 29.297 (± 6.007) μg×h×mL-1; and AUC0-∞ = 29.299 (± 6.007) μg×h×mL-1 for reference formulation and Cmax = 11.456 (± 2.825) μg×mL-1; tmax = 1.331 (± 0.509) h; t1/2 = 1.141 (± 0.133) h; AUC0-tlast = 28.672 (± 5.778) μg×h×mL-1; and AUC0-∞ = 28.693 (± 5.796) μg×h×mL-1 for test formulation. The confidence intervals (90% CI) for reference and test formulations were, respectively, 90.74 - 100.46% for Cmax and 93.62 - 103.61% for AUC0-t.
  
  
  CONCLUSIONS
  Based on the results, both formulations of amoxicillin evaluated in this study were considered bioequivalent according to FDA and ANVISA/Brazil criteria.
authors.forename: Gilson C N
authors.initials: GC
authors.lastname: Franco
authors.forename: Sinvaldo
authors.initials: S
authors.lastname: Baglie
authors.forename: Ana P B
authors.initials: AP
authors.lastname: Ruenis
authors.forename: Luiz M
authors.initials: LM
authors.lastname: Franco
authors.forename: Karina
authors.initials: K
authors.lastname: Cogo
authors.forename: Yoko
authors.initials: Y
authors.lastname: Oshima-Franco
authors.forename: Paulo
authors.initials: P
authors.lastname: Silva
authors.forename: Francisco C
authors.initials: FC
authors.lastname: Groppo
authors.forename: Pedro Luiz
authors.initials: PL
authors.lastname: Rosalen
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001938:Brazil; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D005215:Fasting / Q000097:blood; D005260:Female; D006207:Half-Life; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D013535:Suspensions; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D013535:Suspensions; D000658:Amoxicillin