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Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.

Osteoporosis Clinical Trial

Official title:
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.

Clinical Trial Summary

A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04936984
Study type Interventional
Source Radius Health, Inc.
Contact
Status Completed
Phase Phase 1
Start date November 16, 2020
Completion date August 13, 2021
View Details
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