Medpace Clinical Pharmacology
Cincinnati, Ohio, 45227, United States
NCT Number: NCT04936984
A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.
Looking for future studies?
Notify Me40 year–65 year
Female
Interventional
Phase 1
Cincinnati, Ohio, 45227, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
Other names: abaloparatide-sMTS
single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
Other names: abaloparatide-sMTS
Time frame: 4 single-dose administrations, separated by 48 hours.
Time frame: 4 single-dose administrations, separated by 48 hours.
Time frame: 4 single-dose administrations, separated by 48 hours.
Time frame: 14 ± 2 days
Radius Health, Inc.
Industry
An Open-Label, Randomized, 4-Period Crossover Study Evaluating the Bioequivalence of Two Abaloparatide-sMTS Treatments and the Effect of Small Variations in Wear-Time in Healthy Women.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07725081
Attitudes, Behavior
Afyonkarahisar, Turkey (Türkiye)
View Trial DetailsNCT05541432
Behavior, Bone Diseases
Waterloo, Ontario, Canada
View Trial DetailsNCT03924414
Atypical Parkinsonism, Autonomic Nervous System Diseases
Scottsdale, Arizona, United States
View Trial DetailsNCT02924545
Bone Diseases, Bone Diseases, Metabolic
Nîmes, France
View Trial Details