Pharmacokinetic Study Evaluating Staccato® Alprazolam 1 mg Inhaler in Smokers Versus Non-Smokers
Public ClinicalTrials.gov record NCT03516305. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Open-Label, Non-Randomized, Single-Dose, Pharmacokinetic Study Evaluating Staccato® Alprazolam 1 mg Inhaler in Smoker Versus Non-Smoker Healthy Adult Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, non-randomized, single dose, pharmacokinetic study in 36 healthy adult male and female volunteers, including 18 smokers and 18 non-smokers. All subjects will be administered a single inhaled dose of Staccato alprazolam 1 mg via hand-held inhaler. Blood samples will be drawn for pharmacokinetic analysis. Eligible subjects are admitted to Phase 1 unit for up to 48 hours. Subjects will receive a post-study safety phone call 14 days(± 2 days) after dosing.
Study identification
- NCT ID
- NCT03516305
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 5, 2018
- Primary completion
- Jul 31, 2018
- Completion
- Jul 31, 2018
- Last update posted
- Apr 6, 2022
2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinilabs Research Unit | Eatontown | New Jersey | 07724 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03516305, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 6, 2022 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03516305 live on ClinicalTrials.gov.