Staccato Zaleplon Single Dose Pharmacokinetics

NCT00620620 ↗

Phase 1 Completed 40 enrolled Alexza Pharmaceuticals, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2008-02
Primary completion: 2008-03
Completion: 2008-03

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zaleplon	Small molecule	0.5 mg	Inhaled
Subject	Zaleplon	Small molecule	1 mg	Inhaled
Subject	Zaleplon	Small molecule	2 mg	Inhaled
Subject	Zaleplon	Small molecule	4 mg	Inhaled

Indications

No indication recorded.