NCT02663999

A Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers

A Two-Period, Randomized, Open-Label, Crossover Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, two-period, randomized, open-label, crossover pharmacokinetic (PK) study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray using two dose levels

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	diazepam nasal spray	diazepam nasal spray at two dose levels (DL). One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2016-01-26
• Last updated: 2016-06-13

Locations

1 site across 1 country: United States