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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04936984

Enrollment

Registered

2021-06-23

Start date

2020-11-16

Completion date

2021-08-13

Last updated

2022-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

osteoporosis, transdermal delivery, microneedle patch, solid microstructured transdermal system, abaloparatide TYMLOS®, abaloparatide-SC, PK

Brief 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.

Interventions

COMBINATION_PRODUCTabaloparatide-sMTS (Patheon)

single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes

COMBINATION_PRODUCTabaloparatide-sMTS (Kindeva)

single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

All subjects were to receive a transdermal patch containing 300 μg abaloparatide for 4,5 and 7 minutes in 4 separate periods.

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Female subjects aged 40 to 65 years old, inclusive, at Screening * Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 34 kg/m\^2 inclusive) * Laboratory tests within the normal range * Serum 25-hydroxyvitamin D values must be \> 20 ng/mL

Exclusion criteria

* Presence or history of any disorder that may prevent the successful completion of the study. * Diagnosed with osteoporosis, Paget's disease, or other metabolic bone diseases (eg, vitamin D deficiency or osteomalacia), or had a non-traumatic fracture within 1 year prior to the initial screening; * History of any cancer within the past 5 years other than squamous or basal cell carcinoma; * History of allergy to abaloparatide or drugs in a similar pharmacological class;

Design outcomes

Primary

Measure	Time frame
Maximum observed concentration (Cmax)	4 single-dose administrations, separated by 48 hours.
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)	4 single-dose administrations, separated by 48 hours.
AUC from time 0 extrapolated to time infinity (AUC 0-∞)	4 single-dose administrations, separated by 48 hours.

Secondary

Measure	Time frame
Subjects with treatment-emergent AEs and SAEs	14 ± 2 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026