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

NCT04936984 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-01-06

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Radius Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2021-02-09
Completion
2021-08-13
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04936984 on ClinicalTrials.gov