NCT05626439

A Relative Bioavailability Study of Staccato Alprazolam Versus Oral Alprazolam in Healthy Study Participants

An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study to Evaluate The Relative Bioavailability of Staccato Alprazolam Compared to Oral Alprazolam in Healthy Study Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the relative bioavailability of alprazolam in plasma following a single dose of Staccato alprazolam compared to a single dose of oral alprazolam under fasted conditions

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Staccato alprazolam	Study participants will receive single dose of Staccato alprazolam by inhalation at pre-specified time points.
DRUG	Oral alprazolam	Study participants will receive single dose of oral alprazolam at pre-specified time points.

Timeline

• Start date: 2022-12-28
• Primary completion: 2023-02-24
• Completion: 2023-02-24
• First posted: 2022-11-23
• Last updated: 2024-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study