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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.
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.
Age
40 - 65 years
Sex
FEMALE
Healthy Volunteers
Yes
Medpace Clinical Pharmacology
Cincinnati, Ohio, United States
Start Date
November 16, 2020
Primary Completion Date
February 9, 2021
Completion Date
August 13, 2021
Last Updated
January 6, 2022
36
ACTUAL participants
abaloparatide-sMTS (Patheon)
COMBINATION_PRODUCT
abaloparatide-sMTS (Kindeva)
COMBINATION_PRODUCT
abaloparatide-sMTS (Patheon)
COMBINATION_PRODUCT
abaloparatide-sMTS (Patheon)
COMBINATION_PRODUCT
Lead Sponsor
Radius Health, Inc.
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07281586