Staccato Loxapine Pulmonary Safety in Healthy Volunteers
NCT ID: NCT00789360
Last Updated: 2019-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2008-11-30
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Inhaled Placebo crossed over to Inhaled Loxapine
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart
Inhaled Placebo
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
Inhaled Loxapine
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
Inhaled Loxapine crossed over to Inhaled Placebo
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart;
Inhaled Placebo
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
Inhaled Loxapine
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
Interventions
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Inhaled Placebo
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
Inhaled Loxapine
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Alexza Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David S. Miller, MD
Role: PRINCIPAL_INVESTIGATOR
Northeast Medical Research, North Dartmouth, MA
Locations
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Northeast Medical Research
North Dartmouth, Massachusetts, United States
Countries
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Other Identifiers
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12 September 2008
Identifier Type: -
Identifier Source: secondary_id
AMDC-004-104
Identifier Type: -
Identifier Source: org_study_id
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