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Relative bioavailability between two teriparatide formulations in healthy volunteers
Summary
This study found the test formulation of teriparatide to be bioequivalent to the reference product. Pharmacokinetics, immunogenicity, and safety were comparable, demonstrating similarity between the two teriparatide formulations.
Area of Science:
- Pharmacology
- Clinical Pharmacology
- Bioequivalence Studies
Background:
- Teriparatide is a crucial treatment for osteoporosis.
- Ensuring therapeutic equivalence between different teriparatide formulations is vital for patient care.
- Comparative studies are necessary to establish bioequivalence for generic drug approvals.
Purpose of the Study:
- To compare pharmacokinetics, relative bioavailability (RB), immunogenicity, and safety of a test teriparatide formulation against a reference product.
- To demonstrate the similarity between the test (Osteofortil®) and reference (Forteo®) teriparatide formulations.
- To meet regulatory requirements for bioequivalence.
Main Methods:
- A randomized, open-label, two-period crossover study was conducted in 24 healthy volunteers.
- Single-dose administration of test and reference teriparatide formulations with a 7-day washout period.
- Pharmacokinetic parameters (Cmax, AUC0-t, AUC0-∞) were analyzed using ELISA, alongside immunogenicity and safety monitoring.
Main Results:
- The test and reference formulations showed comparable pharmacokinetic profiles.
- Key ratios (test/reference) for Cmax, AUC0-t, and AUC0-∞ fell within the accepted bioequivalence range (90% CI).
- No adverse events were reported by any subject, indicating a similar safety profile.
Conclusions:
- The test formulation of teriparatide meets the pharmacokinetic criteria for bioequivalence.
- Osteofortil® is demonstrated to be bioequivalent to Forteo®.
- This supports the potential for interchangeable use of both teriparatide formulations.
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