title: Relative bioavailability between two teriparatide formulations in healthy volunteers.
abstract: OBJECTIVE
  To compare the pharmacokinetics, relative bioavailability (RB), immunogenicity, and safety after a single dose of test or reference formulation of teriparatide in healthy human volunteers in order to demonstrate whether both products are similar.
  
  
  METHODS
  We compared pharmacokinetic parameters, immunogenicity, and safety after a single dose of two formulations (Osteofortil® and Forteo®) of teriparatide in a randomizedsequence, open-label, two-period crossover study in 24 healthy volunteers. The washout period between formulations was 7 days. Blood samples were collected at baseline and 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150 minutes, and 3 and 4 hours after administration. Teriparatide concentrations were determined using ELISA. Adverse events were monitored.
  
  
  RESULTS
  Geometric mean (90% CI) Cmax for test and reference formulations were 165.86 (153.35 - 212.13) and 175.37 (164.04 - 221.04) pg/mL, the AUC0-t was 14,932 (5,275 - 15,752) and 14,153 (1,861 - 16,875) pg×min/mL, and the AUC0-∞ was 16,147 (15,047 - 18,799) and 15,467 (14,473 - 18,126) pg×min/mL, respectively. The test/reference ratios (90% CI) for Cmax, AUC0-t, and AUC0-∞ were 94.58% (85.29 - 104.87), 105.5% (97.77 - 113.84), and 104.4% (96.97 - 112.39), respectively No subject reported adverse events.
  
  
  CONCLUSIONS
  Test formulation met pharmacokinetic criteria for bioequivalence.
authors.forename: Javier
authors.initials: J
authors.lastname: Farías
authors.forename: Guillermo A
authors.initials: GA
authors.lastname: Keller
authors.forename: Mariana
authors.initials: M
authors.lastname: Papouchado
authors.forename: María C
authors.initials: MC
authors.lastname: Villa Etchegoyen
authors.forename: Marcelo E
authors.initials: ME
authors.lastname: Criscuolo
authors.forename: Roberto A
authors.initials: RA
authors.lastname: Diez
authors.forename: Guillermo
authors.initials: G
authors.lastname: Di Girolamo
mesh_terms: D000328:Adult; D001682:Biological Availability; D050071:Bone Density Conservation Agents / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008875:Middle Aged; D019379:Teriparatide / Q000009:adverse effects / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide