Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00789360
Status:
COMPLETED
Last Update Posted:
2019-03-11
First Post:
2008-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Staccato Loxapine Pulmonary Safety in Healthy Volunteers
Sponsor:
Alexza Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.
Detailed Description:
The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 12 September 2008 | None | None | View |