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A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TI 30 units (10 unit + 20 unit | Experimental | Technosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge |
|
| TI 30 units (30 unit cartridge | Experimental | Technosphere® Insulin 30 units given as one 30 unit cartridge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technosphere® Insulin 10U + 20U | Drug | Inhaled Insulin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area-under-the-serum insulin concentration versus time curve (AUC0-240min | 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neptune City | New Jersey | 07753 | United States |
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| Technosphere® Insulin 30U |
| Drug |
Inhaled Insulin |
|