Conditions: Healthy
Keywords: Healthy volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: yes

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.

Arms:
arm 1: 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 arm 2: 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;

Interventions: intervention 1: Inhaled Placebo intervention 2: Inhaled Loxapine
Intervention descriptions: intervention 1: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart intervention 2: Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart

Protocol document: