Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT00873769
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2009-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Staccato Loxapine PK in Smokers and Nonsmokers
Sponsor:
Alexza Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
Pharmacokinetics of Staccato® Loxapine for Inhalation in Smokers Compared to Nonsmokers
Status:
COMPLETED
Status Verified Date:
2009-06
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 was to assess the pharmacokinetics of a single dose of 10 mg Staccato Loxapine administered to smokers compared to nonsmokers.
Detailed Description:
Pharmacokinetics and sedation pharmacodynamics were studied using a visual analog scale were studied in male and female adult subjects (nonsmokers and smokers) following a single dose of 10 mg of inhaled loxapine. Blood samples were drawn at predose, 30 seconds, 1, 2, 3, 10, 30, and 60 minutes, and 2, 6, 12, and 24 hours after dosing. Loxapine and 8-OH-loxapine were analyzed using reverse-phase liquid chromatography coupled with a tandem mass spectrometer.
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 |
|---|---|---|---|---|
| 27 February 2009 | None | None | View |