1. Relative bioavailability between two teriparatide formulations in healthy volunteers
- Author
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Marcelo Criscuolo, Guillermo Di Girolamo, Roberto A. Diez, Javier M. Farias, Maria C Villa Etchegoyen, Guillermo Alberto Keller, and Mariana Papouchado
- Subjects
Adult ,Male ,Chemistry, Pharmaceutical ,Cmax ,Biological Availability ,Pharmacology ,Bioequivalence ,Pharmacokinetics ,Teriparatide ,medicine ,Humans ,Pharmacology (medical) ,Adverse effect ,Cross-Over Studies ,Bone Density Conservation Agents ,business.industry ,Middle Aged ,Crossover study ,Healthy Volunteers ,Bioavailability ,Therapeutic Equivalency ,Female ,Geometric mean ,business ,medicine.drug - 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. Research design and 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. Conclusion Test formulation met pharmacokinetic criteria for bioequivalence.
- Published
- 2016