A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.
This is a single site, open-label, randomized, 4-period crossover study to evaluate the bioequivalence of 2 abaloparatide-sMTS 300 μg treatments (Patheon sterile abaloparatide-sMTS and Kindeva ultra-low bioburden abaloparatide-sMTS) applied to the thigh for 5 minutes. The study will also evaluate the effect of small deviations in the wear-time of the Patheon abaloparatide-sMTS worn for 4 minutes or 7 minutes compared to the Patheon abaloparatide-sMTS worn for the prescribed 5 minutes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes
Medpace Clinical Pharmacology
Cincinnati, Ohio, United States
Maximum observed concentration (Cmax)
Time frame: 4 single-dose administrations, separated by 48 hours.
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)
Time frame: 4 single-dose administrations, separated by 48 hours.
AUC from time 0 extrapolated to time infinity (AUC 0-∞)
Time frame: 4 single-dose administrations, separated by 48 hours.
Subjects with treatment-emergent AEs and SAEs
Time frame: 14 ± 2 days
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single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes