Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min | Experimental | Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). |
|
| Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min | Experimental | Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). |
|
| Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min | Experimental | Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). |
|
| Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abaloparatide-sMTS (Patheon) | Combination Product | single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes |
|
| Measure | Description | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects with treatment-emergent AEs and SAEs | 14 ± 2 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace Clinical Pharmacology | Cincinnati | Ohio | 45227 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
All subjects were to receive a transdermal patch containing 300 μg abaloparatide for 4,5 and 7 minutes in 4 separate periods.
Not provided
Not provided
Not provided
Not provided
Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). |
|
|
| abaloparatide-sMTS (Kindeva) | Combination Product | single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes |
|
|
| abaloparatide-sMTS (Patheon) | Combination Product | single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes |
|
|
| abaloparatide-sMTS (Patheon) | Combination Product | single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes |
|
|
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided