Trials / Completed
CompletedNCT04936984
Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.
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.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Radius Health, Inc. · Industry
- Sex
- Female
- Age
- 40 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | abaloparatide-sMTS (Patheon) | single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes |
| COMBINATION_PRODUCT | abaloparatide-sMTS (Kindeva) | single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes |
| COMBINATION_PRODUCT | abaloparatide-sMTS (Patheon) | single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes |
| COMBINATION_PRODUCT | abaloparatide-sMTS (Patheon) | single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes |
Timeline
- Start date
- 2020-11-16
- Primary completion
- 2021-02-09
- Completion
- 2021-08-13
- First posted
- 2021-06-23
- Last updated
- 2022-01-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04936984. Inclusion in this directory is not an endorsement.