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| ID | Type | Description | Link |
|---|---|---|---|
| 17 December 2007 |
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The purpose of the study is to determine the safety, tolerability and pharmacokinetics of zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Placebo | Placebo Comparator | Staccato Placebo |
|
| Inhaled Zaleplon 0.5 mg | Experimental | Staccato Zaleplon 0.5 mg |
|
| Inhaled Zaleplon 1 mg | Experimental | Staccato Zaleplon 1 mg |
|
| Inhaled Zaleplon 2 mg | Experimental | Staccato Zaleplon 2 mg |
|
| Inhaled Zaleplon 4 mg | Experimental | Staccato Zaleplon 4 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled placebo | Drug | Inhaled Staccato Placebo |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population; | Single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses | single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel A Spyker, MD | Alexza Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Evansville | Indiana | 47714 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23436259 | Background | Avram MJ, Spyker DA, Kehne JH, Cassella JV. The pharmacokinetics and pharmacodynamics of zaleplon delivered as a thermally generated aerosol in a single breath to volunteers. J Clin Pharmacol. 2013 Feb;53(2):140-50. doi: 10.1177/0091270012436886. |
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IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
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| Inhaled Zaleplon 0.5 mg | Drug | Inhaled Staccato Zaleplon 0.5 mg |
|
|
| Inhaled Zaleplon 1 mg | Drug | Inhaled Staccato Zaleplon 1 mg |
|
|
| Inhaled Zaleplon 2 mg | Drug | Inhaled Staccato Zaleplon 2 mg |
|
|
| Inhaled Zaleplon 4 mg | Drug | Inhaled Staccato Zaleplon 4 mg |
|
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