We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Multiple dose pharmacokinetics of inhaled loxapine in subjects on chronic, stable antipsychotic regimens.
- Authors
Spyker, Daniel A.; Riesenberg, Robert A.; Cassella, James V.
- Abstract
This randomized, double-blind, placebo-controlled, parallel-group study was to determine the pharmacokinetic characteristics, safety, and tolerability of multiple doses of inhaled loxapine aerosol in subjects on a stable, oral, chronic antipsychotic regimen. Loxapine was delivered by means of a unique thermally generated aerosol comprising drug particles of a size designed for deep lung delivery and absorption. Thirty-two subjects were randomized 1:1:1:1 to receive inhaled loxapine (total doses of 15, 20, or 30 mg) or inhaled placebo administered in 3 divided doses, given 4 hours apart. Following inhalation, the median Tmax was 2 minutes, and concentrations declined to about half Cmax approximately 5 minutes later across the 3 dose levels. The dose proportionality across data from this study combined with data from the single-dose study showed a slope (90%CI) of log AUCinf versus log dose of 0.818 (0.762-0.875) across the 8 doses (n = 60 subjects) studied, indicating reasonable dose proportionality. The most common adverse events were cough (3 of 32, 9%), sedation (3 of 32, 9%), and dysgeusia (2 of 32, 6%). The inhalation of multiple doses of inhaled loxapine were well tolerated in study subjects and provided a safe, well-tolerated means for rapidly and reliably achieving therapeutic plasma concentrations of loxapine. identifier: NCT00555412
- Subjects
PHARMACOKINETICS; ANTIPSYCHOTIC agents; PLACEBOS; DRUG dosage; TASTE disorders; DRUG therapy for schizophrenia; AEROSOLS; ANESTHESIA; COUGH; EXPERIMENTAL design; PATIENT safety; RANDOMIZED controlled trials; BLIND experiment; INHALATION administration
- Publication
Journal of Clinical Pharmacology, 2015, Vol 55, Issue 9, p985
- ISSN
0091-2700
- Publication type
Article
- DOI
10.1002/jcph.502