Staccato Loxapine Multidose PK
Sponsored by Alexza Pharmaceuticals, Inc.
About this trial
Last updated 9 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 18 years ago
What is this trial about?
What are the Participation Requirements?
Inclusion Criteria include: 1. Male and female subjects between the ages of 18 to 65 years, inclusive. 2. Subjects who are on stable, oral, chronic (>2 mos) antipsychotic medication regimen and who are able to tolerate the rapid oral dose taper and substitution regimen. Exclusion Criteria include: 1. Subjects who are currently treated with injectable depot neuroleptics within one dose interval must be excluded. 2. Subjects who have received loxapine or amoxapine within the last 30 days must be excluded. 3. Subjects with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded. 4. Subjects with a history of movement disorders including Parkinson's disease or a history of neuroleptic malignant syndrome must be excluded. 5. Subjects who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.
