Conditions: Migraine
Keywords: Migraine, Prochlorperazine aerosol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 54
Healthy volunteers: yes

Brief summary:
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine

Detailed description:
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of a single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy young volunteers.

Arms:
arm 1: Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg arm 2: Inhaled Staccato prochlorperazine 1.25 mg arm 3: Inhaled Staccato prochlorperazine 2.5 mg arm 4: Inhaled Staccato prochlorperazine 5 mg arm 5: Inhaled Staccato prochlorperazine 10 mg arm 6: inhaled Staccato Placebo (0 mg)

Interventions: intervention 1: Prochlorperazine 0.5 mg IV over 5 sec intervention 2: Inhaled prochlorperazine 0.625 mg intervention 3: Inhaled prochlorperazine 1.25 mg intervention 4: Inhaled prochlorperazine 2.5 mg intervention 5: Inhaled prochlorperazine 5 mg intervention 6: Inhaled prochlorperazine 10 mg intervention 7: Inhaled placebo intervention 8: Prochlorperazine 10 mg IV over 5 sec
Intervention descriptions: intervention 1: IV Prochlorperazine for bioavailability intervention 2: Inhaled Staccato Prochlorperazine 0.625 mg intervention 3: Inhaled Staccato Prochlorperazine 1.25 mg intervention 4: Inhaled Staccato Prochlorperazine 2.5 mg intervention 5: InhaledStaccato Prochlorperazine 5 mg intervention 6: InhaledStaccato Prochlorperazine 10 mg intervention 7: Inhaled Staccato Placebo (0 mg) intervention 8: Prochlorperazine 10 mg IV over 5 sec for patient qualification

Protocol document: