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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| U.S. Army Space and Missile Defense Command | FED |
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MicroDose Defense Products, LLC is developing an atropine dry powder inhaler (ADPI). This pilot study compares the pharmacokinetics (PK) of inhaled dry powder atropine as delivered by the ADPI to atropine delivery from the AtroPen autoinjector.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atropine Dry Powder Inhaler | Experimental |
| |
| Atropen Autoinjector | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atropine sulfate | Drug | dry powder for inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| To characterize pharmacokinetic endpoints for atropine dry powder inhalation (Cmax, Tmax, AUC) and compare these to intramuscular pharmacokinetics (Atropen autoinjector) | Multiple plasma samples collected up to 12 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of atropine dry powder inhalation (Clinical Labs testing, Pulse, Pulse Oximetry, Temperature, Heart Rate, Pulmonary Function Tests, Respiratory Rate, Near Point of Accommodation, Pupil Size). | up to 36 days (including 14 day screening period) |
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Inclusion Criteria:
Exclusion Criteria:
from testing and receive appropriate care and referral from the study physician
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| Name | Affiliation | Role |
|---|---|---|
| Michael Donahoe, M.D. | Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh | Principal Investigator |
| Timothy Corcoran, Ph.D. | Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Hospital Clinical and Translational Research Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| Label | URL |
|---|---|
| Product Description | View source |
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| ID | Term |
|---|---|
| D062025 | Organophosphate Poisoning |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| atropine sulfate | Drug | intramuscular injection |
|
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |